A Phase 1 interventional study of E7130 and E7130 in Solid Tumors, sponsored by Eisai Co., Ltd.. Terminated at 9 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Eisai Co., Ltd. · Phase 1, Interventional, and Treatment
The trial was prematurely terminated due to the sponsor's decision.
The primary objective of this study is to evaluate the tolerability and safety profile of E7130 in participants with solid tumors.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's enrollment of 62 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Eisai Co., Ltd. is the lead sponsor of 152 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion Criteria (Part 2 only):
meeting the following criteria:
Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease to be deemed a target lesion.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Part 1 (Cycle 1; 28 days): The first cohort of 3 participants will receive 25 micrograms per meters squared (μg/m\^2) of E7130, on Day 1 and Day 15 as an intravenous infusion. If a drug-related Grade 2 or higher toxicity excluding clinically insignificant events is not observed in the initial cohort, dose-limiting toxicities (DLTs) will be evaluated in successive dose levels with single participants until such a toxicity is observed. Once the maximum tolerated dose (MTD) will be determined. Part 2: Participants with squamous cell carcinoma of the head and neck and urothelial carcinoma will be evaluated at the dose level determined in Part 1 in a 2-week or in a 3-week regimen based on the evaluations in Part 1.
Drug: E7130
Part 1 (Cycle 1; 21 days): On Day 1, participants will receive E7130 at (-1) a lower dose than the dose at which the first DLT was observed in the 2-week regimen. Once the MTD will be determined. Part 2: Participants with squamous cell carcinoma of the head and neck and urothelial carcinoma will be evaluated at the dose level determined in Part 1 in a 3-week or in a 2-week regimen based on the evaluations in Part 1.
Drug: E7130
Starting dose of 25 μg/m\^2 on Day 1 and Day 15 of Cycle 1.
Starting dose is lower than one at which the first DLT was observed in the 2-week regimen administered on Day 1 of Cycle 1.
Part 1: Number of Participants Assigned to Every 2 Weeks Regimen With Dose-limiting Toxicities (DLTs)
DLTs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. DLTs were defined as the following events that occurred in Cycle 1, for which a causal relationship with E7130 could not be ruled out: febrile neutropenia; Grade 4 neutropenia; Grade 4 thrombocytopenia; Grade 4 anemia or anemia requiring red blood cell transfusion; any Grade 3 non-hematologic toxicity, except for abnormal clinical laboratory values without clinical significance or events manageable and controllable to Grade 2 or less with maximal medical management; any Grade 4 non-hematologic toxicity.
Time frame: Cycle 1 (Cycle length=28 days)
Part 1: Number of Participants Assigned to Every 3 Weeks Regimen With DLTs
DLTs were graded according to the NCI CTCAE version 4.03. DLTs were defined as the following events that occurred in Cycle 1, for which a causal relationship with E7130 could not be ruled out: febrile neutropenia; Grade 4 neutropenia; Grade 4 thrombocytopenia; Grade 4 anemia or anemia requiring red blood cell transfusion; any Grade 3 non-hematologic toxicity, except for abnormal clinical laboratory values without clinical significance or events manageable and controllable to Grade 2 or less with maximal medical management; any Grade 4 non-hematologic toxicity.
Time frame: Cycle 1 (Cycle length=21 days)
Part 1 and Part 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE was defined per NCI CTCAE version 4.03 as an adverse event that emerged up to 30 days after the participant's last dose, having been absent at pretreatment (baseline) or (omitted). An AE was defined as any untoward medical occurrence in a participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product.
Time frame: From start of the study up to 82.5 months
Part 1 and Part 2: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Value (Hematology Parameters)
Number of participants with abnormal laboratory values were assessed and reported. Laboratory evaluations included hematology parameters such as hemoglobin (gram/liter \[g/L\]), platelets (10\^9/L), leukocytes (10\^9/L), neutrophils (10\^9/L), and lymphocytes (10\^9/L) assessed for markedly abnormal low or high values. Treatment-emergent markedly abnormal laboratory value was defined as a postbaseline laboratory value with grade 3 or higher, and with a grade increase from baseline. Laboratory results were graded using CTCAE version 4.03. CTCAE grades 1 through 5, where grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life threatening), and grade 5 (death).
Time frame: From baseline up to 82.5 months
Part 1 and Part 2: Change From Baseline in Arterial Oxygen Saturation
Change from baseline in arterial oxygen saturation was reported.
Time frame: From baseline up to 82.5 months
Part 1 and Part 2: Number of Participants With Any Clinically Significant 12-lead Electrocardiogram (ECG) Value
12-lead ECGs were performed to assess cardiac parameters including QT interval corrected for heart rate (QTc), QTc using the Fridericia formula (QTcF). QTcF abnormalities were summarized for increases of greater than (\>) 30 milliseconds (msec), \>60 msec, and absolute QTcF values \>450, \>480, and \>500 msec.
Time frame: From baseline up to 82.5 months
Number of Participants by Worst Post Dose Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score
ECOG performance score was measured on 6 point scale to assess participant's performance status, where: Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; Grade 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled, cannot carry on any selfcare. Totally confined to bed or chair; Grade 5: Dead.
Time frame: From baseline up to 82.5 months
Part 1: Maximum Tolerated Dose (MTD) of E7130
A dose with the smallest difference between the target DLT rate of 25% and an estimate of DLT rate for each dose was defined as the MTD. DLTs were defined as the following events that occurred in Cycle 1 and Cycle 2, for which a causal relationship with E7130 could not be ruled out: febrile neutropenia; Grade 4 neutropenia; Grade 4 thrombocytopenia; Grade 4 anemia or anemia requiring red blood cell transfusion; any Grade 3 non-hematologic toxicity, except for abnormal clinical laboratory values without clinical significance or events manageable and controllable to Grade 2 or less with maximal medical management; any Grade 4 non-hematologic toxicity.
Time frame: Cycle 1 and 2 (56 days [Q2W regimen] [Cycle length = 28 days], 42 days [Q3W regimen] [Cycle length = 21 days])
Part 1: Cmax: Maximum Observed Plasma Concentration for E7130
Time frame: Bi-weekly: Cycles 1-2 Day 1: 0-168 hours post-infusion (each Cycle length=28 days); Tri-weekly: Cycles 1-2 Day 1: 0-336 hours post-infusion (each Cycle length=21 days)
Part1: Tmax: Time to Reach Cmax of E7130
Tmax was defined as the time to reach maximum observed plasma concentration for E7130.
Time frame: Bi-weekly: Cycles 1-2 Day 1: 0-168 hours post-infusion (each Cycle length=28 days); Tri-weekly: Cycles 1-2 Day 1: 0-336 hours post-infusion (each Cycle length=21 days)
Part 1: AUC 0-inf: Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time for E7130
AUC(0-inf) was defined as the area under the plasma concentration-time curve from 0 time to infinity.
Time frame: Bi-weekly: Cycle 1 Day 1: 0-168 hours post-infusion (each Cycle length=28 days); Tri-weekly: Cycle 1 Day 1: 0-336 hours post-infusion (each Cycle length=21 days)
Part 1: T1/2: Terminal Half-life of E7130
Time frame: Bi-weekly: Cycles 1-2 Day 1: 0-168 hours post-infusion (each Cycle length=28 days); Tri-weekly: Cycles 1-2 Day 1: 0-336 hours post-infusion (each Cycle length=21 days)
Part 1: CL: Total Clearance of E7130
Time frame: Bi-weekly: Cycles 1-2 Day 1: 0-168 hours post-infusion (each Cycle length=28 days); Tri-weekly: Cycles 1-2 Day 1: 0-336 hours post-infusion (each Cycle length=21 days)
Part 1: Vd: Volume of Distribution of E7130
Time frame: Bi-weekly: Cycles 1-2 Day 1: 0-168 hours post-infusion (each Cycle length=28 days); Tri-weekly: Cycles 1-2 Day 1: 0-336 hours post-infusion (each Cycle length=21 days)
Part 1 and Part 2: Recommended Dose for Future Studies
Time frame: From start of the study up to 82.5 months
Part 1 and Part 2: Number of Participants Achieving Best Overall Response (BOR)
The BOR was based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. BOR was defined as complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), and not evaluable (NE), where SD was achieved at \>=5 weeks after the first dose. BOR of CR or PR in Part 1 of this study required no confirmation of the next response at \>=4 weeks. Part 2 required confirmation. Complete response was defined as disappearance of all target lesions. All lymph nodes selected as target lesions had reduction in short axis to \<10 millimeter (mm). Partial response was defined as at least a 30% decrease in the diameter sum of target lesions, taking as reference the baseline diameter sum. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taken as reference the smallest diameter sum while on study.
Time frame: Part 1 and 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 82.5 months)
Part 1 and 2: Objective Response Rate (ORR)
ORR was defined as the percentage of participants who achieved a best overall response of confirmed partial response (PR) or complete response (CR). CR was defined as disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to less than \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Part 1 and 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 82.5 months)
Part 1 and Part 2: Disease Control Rate (DCR)
DCR was defined as the percentage of participants with BOR of CR, PR or SD.
Time frame: Part 1 and 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 82.5 months)
Part 1 and Part 2: Clinical Benefit Rate (CBR)
CBR was defined as the percentage of participants with BOR of CR, PR or durable SD (duration of SD \>=23 weeks). Duration of SD was defined as the time from the date of first dose to the date of the first documentation of disease progression or death from any cause, whichever occurred first. It was calculated for participants whose BOR was SD.
Time frame: Part 1 and 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 82.5 months)
Part 2: Progression-free Survival (PFS)
PFS was defined as the time from the date of first dose to the first documented date of event (disease progression or death from any cause, whichever occurred first). PD based on RECIST v1.1 was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum diameters while on study.
Time frame: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 82.5 months)
Part 2: Duration of Response (DoR)
DOR was defined as the time from the first documented date of PR or CR to the first documented date of event (disease progression or death from any cause, whichever occurred first). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Here, "number analyzed" signifies participants who had CR or PR.
Time frame: Part 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 82.5 months)
Part 2: Overall Survival (OS)
OS was defined as the time from the date of first dose to the date of death from any cause. For the participants who were alive or unknown, OS was censored as the date of last known alive date or the date of data cut off, whichever came first.
Time frame: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 82.5 months)
Percent Change From Baseline in Sum of Diameters of Target Tumor Lesions
Percent change from baseline in the sum of diameters of target lesions was reported. Tumor measurements were performed according to RECIST version 1.1, where the longest diameter was used for non-nodal lesions and the short-axis diameter was used for nodal lesions.
Time frame: From baseline up to 82.5 months
Participants took part in the study at 9 investigative sites in Japan from 05 February 2018 to 27 December 2024.
| Milestone | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W | Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 4 | 1 | 1 | 1 | 3 | 13 | 6 | 3 | 3 | 7 | 2 | 7 | 2 | 3 | 6 |
| Treated | 4 | 1 | 1 | 1 | 3 | 13 | 6 | 3 | 3 | 7 | 2 | 7 | 2 | 3 | 6 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 4 | 1 | 1 | 1 | 3 | 13 | 6 | 3 | 3 | 7 | 2 | 7 | 2 | 3 | 6 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Clinical disease progression | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Radiological disease progression | 4 | 1 | 1 | 1 | 3 | 10 | 4 | 3 | 2 | 7 | 2 | 4 | 1 | 2 | 2 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 4 |
DLTs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. DLTs were defined as the following events that occurred in Cycle 1, for which a causal relationship with E7130 could not be ruled out: febrile neutropenia; Grade 4 neutropenia; Grade 4 thrombocytopenia; Grade 4 anemia or anemia requiring red blood cell transfusion; any Grade 3 non-hematologic toxicity, except for abnormal clinical laboratory values without clinical significance or events manageable and controllable to Grade 2 or less with maximal medical management; any Grade 4 non-hematologic toxicity.
| Participants | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W |
|---|---|---|---|---|---|---|---|
| Part 1: Number of Participants Assigned to Every 2 Weeks Regimen With Dose-limiting Toxicities (DLTs) | 0 | 0 | 0 | 0 | 0 | 6 | 2 |
DLTs were graded according to the NCI CTCAE version 4.03. DLTs were defined as the following events that occurred in Cycle 1, for which a causal relationship with E7130 could not be ruled out: febrile neutropenia; Grade 4 neutropenia; Grade 4 thrombocytopenia; Grade 4 anemia or anemia requiring red blood cell transfusion; any Grade 3 non-hematologic toxicity, except for abnormal clinical laboratory values without clinical significance or events manageable and controllable to Grade 2 or less with maximal medical management; any Grade 4 non-hematologic toxicity.
| Participants | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W |
|---|---|---|---|---|
| Part 1: Number of Participants Assigned to Every 3 Weeks Regimen With DLTs | 0 | 0 | 0 | 2 |
TEAE was defined per NCI CTCAE version 4.03 as an adverse event that emerged up to 30 days after the participant's last dose, having been absent at pretreatment (baseline) or (omitted). An AE was defined as any untoward medical occurrence in a participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product.
| Participants | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W | Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 and Part 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 4 | 1 | 1 | 1 | 3 | 13 | 6 | 3 | 3 | 7 | 2 | 7 | 2 | 3 | 6 |
Number of participants with abnormal laboratory values were assessed and reported. Laboratory evaluations included hematology parameters such as hemoglobin (gram/liter \[g/L\]), platelets (10\^9/L), leukocytes (10\^9/L), neutrophils (10\^9/L), and lymphocytes (10\^9/L) assessed for markedly abnormal low or high values. Treatment-emergent markedly abnormal laboratory value was defined as a postbaseline laboratory value with grade 3 or higher, and with a grade increase from baseline. Laboratory results were graded using CTCAE version 4.03. CTCAE grades 1 through 5, where grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life threatening), and grade 5 (death).
| Participants | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W | Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hemoglobin: Markedly Abnormal Low | 0 | 0 | 0 | 0 | 2 | 2 | 3 | 0 | 2 | 3 | 2 | 2 | 0 | 1 | 1 |
| Leukocytes: Markedly Abnormal Low | 0 | 0 | 0 | 0 | 2 | 7 | 1 | 0 | 1 | 4 | 2 | 5 | 1 | 1 | 3 |
| Neutrophils: Markedly Abnormal Low | 0 | 0 | 0 | 0 | 0 | 10 | 5 | 0 | 2 | 5 | 2 | 4 | 2 | 1 | 3 |
| Lymphocytes: Markedly Abnormal Low | 0 | 0 | 0 | 0 | 1 | 4 | 1 | 1 | 1 | 2 | 1 | 3 | 1 | 0 | 0 |
Change from baseline in arterial oxygen saturation was reported.
| percentage (%) of oxygen | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W | Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 and Part 2: Change From Baseline in Arterial Oxygen Saturation | 0.3 ± 0.58 | — | — | 1.0 ± NA | -3.0 ± 5.66 | 0.6 ± 1.03 | 0.2 ± 1.10 | 2.0 ± NA | 2.5 ± 2.12 | -0.6 ± 0.89 | 0.5 ± 0.71 | -2.5 ± 4.51 | — | 1.00 ± 0 | 0 ± 0 |
12-lead ECGs were performed to assess cardiac parameters including QT interval corrected for heart rate (QTc), QTc using the Fridericia formula (QTcF). QTcF abnormalities were summarized for increases of greater than (\>) 30 milliseconds (msec), \>60 msec, and absolute QTcF values \>450, \>480, and \>500 msec.
| Participants | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W | Part 2: SCCHN E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| At least one post-baseline increase of >30 msec | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| At least one post-baseline increase of >60 msec | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| At least one post-baseline value of >450 msec | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| At least one post-baseline value of >480 msec | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| At least one post-baseline value of >500 msec | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
ECOG performance score was measured on 6 point scale to assess participant's performance status, where: Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; Grade 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled, cannot carry on any selfcare. Totally confined to bed or chair; Grade 5: Dead.
| Participants | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W | Part 2: SCCHN E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Scale Performance Status: 0 | 0 | 1 | 0 | 0 | 3 | 5 | 1 | 0 | 0 | 3 | 0 | 0 | 0 | 1 | 1 |
| Scale Performance Status: 1 | 4 | 0 | 1 | 1 | 0 | 6 | 2 | 3 | 3 | 3 | 1 | 1 | 1 | 2 | 4 |
| Scale Performance Status: 2 | 0 | 0 | 0 | 0 | 0 | 2 | 3 | 0 | 0 | 0 | 1 | 4 | 1 | 0 | 0 |
| Scale Performance Status: 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 0 |
| Scale Performance Status: 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Scale Performance Status: 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
A dose with the smallest difference between the target DLT rate of 25% and an estimate of DLT rate for each dose was defined as the MTD. DLTs were defined as the following events that occurred in Cycle 1 and Cycle 2, for which a causal relationship with E7130 could not be ruled out: febrile neutropenia; Grade 4 neutropenia; Grade 4 thrombocytopenia; Grade 4 anemia or anemia requiring red blood cell transfusion; any Grade 3 non-hematologic toxicity, except for abnormal clinical laboratory values without clinical significance or events manageable and controllable to Grade 2 or less with maximal medical management; any Grade 4 non-hematologic toxicity.
| mcg/m^2 | Part 1: E7130 Q2W Regimen | Part 1: E7130 Q3W Regimen |
|---|---|---|
| Part 1: Maximum Tolerated Dose (MTD) of E7130 | 350 | 480 |
| nanograms per milliliter (ng/mL) | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W (Infusion Time 120 Minutes) | Part 1: E7130 400 mcg/m^2 Q2W (Infusion Time 60 Minutes) | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 1.39 ± 0.373 | 1.83 ± NA | 1.10 ± NA | 3.51 ± NA | 3.06 ± 0.596 | 4.12 ± 1.18 | 2.43 ± 0.286 | 4.61 ± 0.811 | 2.81 ± 0.473 | 5.31 ± 0.276 | 5.07 ± 0.885 | 6.55 ± 2.43 |
| Cycle 2 Day 1 | 1.99 ± 0.308 | 1.33 ± NA | 0.603 ± NA | 3.05 ± NA | 3.20 ± 0.774 | 3.88 ± 0.518 | — | — | 2.30 ± 0.428 | 5.22 ± 0.116 | 4.76 ± 0.402 | — |
Tmax was defined as the time to reach maximum observed plasma concentration for E7130.
| hours | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W (Infusion Time 120 Minutes) | Part 1: E7130 400 mcg/m^2 Q2W (Infusion Time 60 Minutes) | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 0.09 (0.08 to 0.10) | 0.18 (NA to NA) | 0.25 (NA to NA) | 0.75 (NA to NA) | 0.73 (0.33 to 1.02) | 0.73 (0.32 to 1.08) | 1.50 (1.48 to 1.50) | 0.75 (0.33 to 0.75) | 0.75 (0.75 to 0.75) | 0.75 (0.75 to 0.75) | 0.73 (0.33 to 0.75) | 0.74 (0.73 to 0.75) |
| Cycle 2 Day 1 | 0.08 (0.08 to 0.10) | 0.17 (NA to NA) | 0.25 (NA to NA) | 0.73 (NA to NA) | 0.75 (0.73 to 0.75) | 0.53 (0.32 to 0.75) | — | — | 0.35 (0.32 to 0.75) | 0.73 (0.33 to 0.75) | 0.73 (0.32 to 0.75) | — |
AUC(0-inf) was defined as the area under the plasma concentration-time curve from 0 time to infinity.
| nanogram*hour per milliliter (ng*hr/mL) | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W (Infusion Time 120 Minutes) | Part 1: E7130 400 mcg/m^2 Q2W (Infusion Time 60 Minutes) | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1: AUC 0-inf: Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time for E7130 | 1.14 ± 0.250 | 2.87 ± NA | 3.70 ± NA | 14.7 ± NA | 14.6 ± 2.91 | 23.5 ± 6.18 | 29.2 ± 2.14 | 26.2 ± 4.18 | 13.5 ± 3.18 | 24.2 ± 2.35 | 24.4 ± 3.11 | 34.1 ± 9.33 |
| hours | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W (Infusion Time 120 Minutes) | Part 1: E7130 400 mcg/m^2 Q2W (Infusion Time 60 Minutes) | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 62.3 ± 13.7 | 76.6 ± NA | 52.9 ± NA | 74.3 ± NA | 75.4 ± 9.14 | 86.7 ± 18.2 | 84.3 ± 15.0 | 93.1 ± 16.5 | 70.8 ± 2.11 | 74.5 ± 7.67 | 78.3 ± 7.98 | 103 ± 35.6 |
| Cycle 2 Day 1 | 71.3 ± 11.7 | 62.8 ± NA | 58.2 ± NA | 81.1 ± NA | 63.6 ± 10.3 | 70.2 ± 20.0 | — | — | 116 ± 73.8 | 69.0 ± 3.50 | 68.0 ± 1.96 | — |
| liters per hour per square meter | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W (Infusion Time 120 Minutes) | Part 1: E7130 400 mcg/m^2 Q2W (Infusion Time 60 Minutes) | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 22.7 ± 5.30 | 17.4 ± NA | 27.0 ± NA | 13.6 ± NA | 21.1 ± 3.82 | 15.9 ± 4.41 | 13.8 ± 1.01 | 15.5 ± 2.36 | 20.6 ± 4.24 | 17.1 ± 1.65 | 20.0 ± 2.91 | 16.8 ± 4.60 |
| Cycle 2 Day 1 | 15.8 ± 3.35 | 18.2 ± NA | 26.1 ± NA | 14.8 ± NA | 19.4 ± 8.12 | 17.3 ± 5.62 | — | — | 19.0 ± 4.46 | 17.0 ± 3.33 | 17.9 ± 1.67 | — |
| liters per square meter (L/m^2) | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W (Infusion Time 120 Minutes) | Part 1: E7130 400 mcg/m^2 Q2W (Infusion Time 60 Minutes) | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 1420 ± 165 | 1300 ± NA | 1670 ± NA | 1140 ± NA | 1620 ± 202 | 1410 ± 275 | 1340 ± 274 | 1560 ± 96.1 | 1500 ± 269 | 1350 ± 106 | 1620 ± 314 | 1690 ± 141 |
| Cycle 2 Day 1 | 1130 ± 158 | 1300 ± NA | 1930 ± NA | 1320 ± NA | 1540 ± 226 | 1210 ± 267 | — | — | 2360 ± 1420 | 1190 ± 122 | 1280 ± 150 | — |
| mcg/m^2 | Part 1: E7130 Q2W Regimen | Part 1: E7130 Q3W Regimen | Part 2, SCCHN and UC: E7130 Q3W Regimen |
|---|---|---|---|
| Part 1 and Part 2: Recommended Dose for Future Studies | NA | NA | NA |
The BOR was based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. BOR was defined as complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), and not evaluable (NE), where SD was achieved at \>=5 weeks after the first dose. BOR of CR or PR in Part 1 of this study required no confirmation of the next response at \>=4 weeks. Part 2 required confirmation. Complete response was defined as disappearance of all target lesions. All lymph nodes selected as target lesions had reduction in short axis to \<10 millimeter (mm). Partial response was defined as at least a 30% decrease in the diameter sum of target lesions, taking as reference the baseline diameter sum. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taken as reference the smallest diameter sum while on study.
| Participants | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W | Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CR | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| PR | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| SD | 1 | 1 | 0 | 0 | 1 | 4 | 4 | 2 | 2 | 3 | 2 | 4 | 2 | 3 | 1 |
| Unconfirmed CR | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unconfirmed PR | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PD | 3 | 0 | 1 | 1 | 2 | 7 | 1 | 1 | 1 | 4 | 0 | 3 | 0 | 0 | 0 |
| NE | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
ORR was defined as the percentage of participants who achieved a best overall response of confirmed partial response (PR) or complete response (CR). CR was defined as disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to less than \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| percentage of participants | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W | Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 and 2: Objective Response Rate (ORR) | 0.0 (0.0 to 60.2) | 0.0 (0.0 to 97.5) | 0.0 (0.0 to 97.5) | 0.0 (0 to 97.5) | 0.0 (0.0 to 70.8) | 15.4 (1.9 to 45.4) | 0.0 (0 to 45.9) | 0.0 (0 to 70.8) | 0.0 (0 to 70.8) | 0.0 (0 to 41.0) | 0.0 (0 to 84.2) | 0.0 (0 to 41.0) | 0.0 (0 to 84.2) | 0.0 (0 to 70.8) | 66.7 (22.3 to 95.7) |
DCR was defined as the percentage of participants with BOR of CR, PR or SD.
| percentage of participants | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W | Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 and Part 2: Disease Control Rate (DCR) | 25.0 (0.6 to 80.6) | 100.0 (2.5 to 100) | 0.0 (0 to 97.5) | 0.0 (0 to 97.5) | 33.3 (0.8 to 90.6) | 46.2 (19.2 to 74.9) | 66.7 (22.3 to 95.7) | 66.7 (9.4 to 99.2) | 66.7 (9.4 to 99.2) | 42.9 (9.9 to 81.6) | 100.0 (15.8 to 100) | 57.1 (18.4 to 90.1) | 100.0 (15.8 to 100) | 100.0 (29.2 to 100) | 83.3 (35.9 to 99.6) |
CBR was defined as the percentage of participants with BOR of CR, PR or durable SD (duration of SD \>=23 weeks). Duration of SD was defined as the time from the date of first dose to the date of the first documentation of disease progression or death from any cause, whichever occurred first. It was calculated for participants whose BOR was SD.
| percentage of participants | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W | Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 and Part 2: Clinical Benefit Rate (CBR) | 0.0 (0 to 60.2) | 0.0 (0 to 97.5) | 0.0 (0 to 97.5) | 0.0 (0 to 97.5) | 0.0 (0 to 70.8) | 23.1 (5.0 to 53.8) | 33.3 (4.3 to 77.7) | 33.3 (0.8 to 90.6) | 33.3 (0.8 to 90.6) | 14.3 (0.4 to 57.9) | 0.0 (0 to 84.2) | 14.3 (0.4 to 57.9) | 0.0 (0 to 84.2) | 0.0 (0 to 70.8) | 66.7 (22.3 to 95.7) |
PFS was defined as the time from the date of first dose to the first documented date of event (disease progression or death from any cause, whichever occurred first). PD based on RECIST v1.1 was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum diameters while on study.
| months | Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W |
|---|---|---|---|---|
| Part 2: Progression-free Survival (PFS) | 3.5 (0.4 to 19.6) | 2.8 (1.1 to 2.8) | 2.6 (2.6 to 3.0) | 6.6 (1.0 to 9.4) |
DOR was defined as the time from the first documented date of PR or CR to the first documented date of event (disease progression or death from any cause, whichever occurred first). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Here, "number analyzed" signifies participants who had CR or PR.
| months | Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W |
|---|---|---|---|---|
| Part 2: Duration of Response (DoR) | — | — | — | 6.6 (1.4 to 8.2) |
OS was defined as the time from the date of first dose to the date of death from any cause. For the participants who were alive or unknown, OS was censored as the date of last known alive date or the date of data cut off, whichever came first.
| months | Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W |
|---|---|---|---|---|
| Part 2: Overall Survival (OS) | 5.0 (1.7 to 20.3) | 7.7 (1.1 to 7.7) | 11.9 (5.7 to 14.6) | 10.7 (5.3 to 36.8) |
Percent change from baseline in the sum of diameters of target lesions was reported. Tumor measurements were performed according to RECIST version 1.1, where the longest diameter was used for non-nodal lesions and the short-axis diameter was used for nodal lesions.
| percent change | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W | Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2: UC E7130 410 mcg/m^2 Q3W | Part 2: UC E7130 480 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Percent Change From Baseline in Sum of Diameters of Target Tumor Lesions | 7.14 ± 11.041 | 7.28 ± NA | 2.44 ± NA | 17.17 ± NA | 25.81 ± 13.148 | -0.70 ± 29.248 | -6.98 ± 6.592 | 2.20 ± 4.238 | 2.50 ± 16.326 | 19.61 ± 30.573 | -39.32 ± NA | 14.42 ± 18.319 | -14.38 ± 6.784 | 3.14 ± 13.587 | -35.83 ± 21.361 |
Collected over From start of the study up to 83 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: E7130 25 mcg/m^2 Q2W | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Part 1: E7130 50 mcg/m^2 Q2W | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Part 1: E7130 100 mcg/m^2 Q2W | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) |
| Part 1: E7130 200 mcg/m^2 Q2W | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| Part 1: E7130 300 mcg/m^2 Q2W | 1/3 (33.3%) | 1/3 (33.3%) | 3/3 (100%) |
| Part 1: E7130 350 mcg/m^2 Q2W | 0/13 (0%) | 3/13 (23.1%) | 13/13 (100%) |
| Part 1: E7130 400 mcg/m^2 Q2W | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Part 1: E7130 270 mcg/m^2 Q3W | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Part 1: E7130 410 mcg/m^2 Q3W | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Part 1: E7130 480 mcg/m^2 Q3W | 0/7 (0%) | 3/7 (42.9%) | 7/7 (100%) |
| Part 1: E7130 550 mcg/m^2 Q3W | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | 7/7 (100%) | 7/7 (100%) | 7/7 (100%) |
| Part 2, SCCHN: 480 mcg/m^2 Q3W | 1/2 (50%) | 1/2 (50%) | 2/2 (100%) |
| Part 2, UC: E7130 410 mcg/m^2 Q3W | 3/3 (100%) | 0/3 (0%) | 3/3 (100%) |
| Part 2, UC: E7130 480 mcg/m^2 Q3W | 5/6 (83.3%) | 4/6 (66.7%) | 6/6 (100%) |
| Event | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W | Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| General physical health deteriorationGeneral disorders | 0/4 | 0/1 | 1/1 | 0/1 | 0/3 | 0/13 | 0/6 | 0/3 | 0/3 | 0/7 | 0/2 | 0/7 | 0/2 | 0/3 | 0/6 |
| Pneumonia aspirationInfections and infestations | 0/4 | 0/1 | 0/1 | 1/1 | 0/3 | 0/13 | 0/6 | 0/3 | 0/3 | 0/7 | 0/2 | 2/7 | 0/2 | 0/3 | 0/6 |
| MalaiseGeneral disorders | 0/4 | 0/1 | 0/1 | 0/1 | 0/3 | 0/13 | 0/6 | 0/3 | 0/3 | 0/7 | 0/2 | 0/7 | 1/2 | 0/3 | 0/6 |
| JaundiceHepatobiliary disorders | 0/4 | 0/1 | 0/1 | 0/1 | 1/3 | 0/13 | 0/6 | 0/3 | 0/3 | 0/7 | 0/2 | 0/7 | 0/2 | 0/3 | 0/6 |
| PneumoniaInfections and infestations | 0/4 | 0/1 | 0/1 | 0/1 | 0/3 | 1/13 | 0/6 | 0/3 | 0/3 | 0/7 | 0/2 | 2/7 | 0/2 | 0/3 | 0/6 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/4 | 0/1 | 0/1 | 0/1 | 0/3 | 0/13 | 0/6 | 0/3 | 0/3 | 1/7 | 0/2 | 1/7 | 0/2 | 0/3 | 1/6 |
| Angular cheilitisGastrointestinal disorders | 0/4 | 0/1 | 0/1 | 0/1 | 0/3 | 0/13 | 0/6 | 0/3 | 0/3 | 0/7 | 0/2 | 1/7 | 0/2 | 0/3 | 1/6 |
| IleusGastrointestinal disorders | 0/4 | 0/1 | 0/1 | 0/1 | 0/3 | 0/13 | 0/6 | 0/3 | 0/3 | 0/7 | 0/2 | 0/7 | 0/2 | 0/3 | 1/6 |
| Decreased appetiteMetabolism and nutrition disorders | 0/4 | 0/1 | 0/1 | 0/1 | 0/3 | 0/13 | 0/6 | 0/3 | 0/3 | 0/7 | 0/2 | 1/7 | 0/2 | 0/3 | 1/6 |
| Peripheral sensory neuropathyNervous system disorders | 0/4 | 0/1 | 0/1 | 0/1 | 0/3 | 0/13 | 0/6 | 0/3 | 0/3 | 0/7 | 0/2 | 0/7 | 0/2 | 0/3 | 1/6 |
| Event | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W | Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/4 | 0/1 | 0/1 | 1/1 | 1/3 | 2/13 | 4/6 | 1/3 | 1/3 | 4/7 | 2/2 | 3/7 | 1/2 | 2/3 | 3/6 |
| LeukopeniaBlood and lymphatic system disorders | 1/4 | 0/1 | 0/1 | 0/1 | 3/3 | 13/13 | 6/6 | 1/3 | 2/3 | 7/7 | 2/2 | 7/7 | 2/2 | 1/3 | 3/6 |
| NeutropeniaBlood and lymphatic system disorders | 1/4 | 0/1 | 0/1 | 0/1 | 2/3 | 13/13 | 5/6 | 0/3 | 2/3 | 6/7 | 2/2 | 7/7 | 2/2 | 1/3 | 3/6 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/4 | 0/1 | 0/1 | 0/1 | 2/3 | 3/13 | 0/6 | 0/3 | 1/3 | 1/7 | 2/2 | 2/7 | 1/2 | 1/3 | 4/6 |
| ConstipationGastrointestinal disorders | 1/4 | 1/1 | 0/1 | 0/1 | 1/3 | 5/13 | 3/6 | 0/3 | 0/3 | 4/7 | 1/2 | 5/7 | 1/2 | 2/3 | 6/6 |
| DiarrhoeaGastrointestinal disorders | 0/4 | 0/1 | 0/1 | 0/1 | 1/3 | 3/13 | 1/6 | 0/3 | 0/3 | 0/7 | 2/2 | 2/7 | 0/2 | 0/3 | 1/6 |
| NauseaGastrointestinal disorders | 2/4 | 0/1 | 1/1 | 1/1 | 2/3 | 9/13 | 5/6 | 1/3 | 1/3 | 4/7 | 2/2 | 1/7 | 0/2 | 0/3 | 2/6 |
| StomatitisGastrointestinal disorders | 0/4 | 1/1 | 0/1 | 0/1 | 0/3 | 5/13 | 1/6 | 0/3 | 1/3 | 2/7 | 2/2 | 0/7 | 0/2 | 0/3 | 3/6 |
| FatigueGeneral disorders | 0/4 | 0/1 | 1/1 | 0/1 | 3/3 | 7/13 | 4/6 | 1/3 | 3/3 | 5/7 | 1/2 | 1/7 | 0/2 | 1/3 | 0/6 |
| MalaiseGeneral disorders | 0/4 | 0/1 | 0/1 | 0/1 | 0/3 | 2/13 | 1/6 | 0/3 | 0/3 | 0/7 | 0/2 | 3/7 | 2/2 | 1/3 | 5/6 |
The safety analysis set included group of participants who received at least 1 dose of the study drug.
| Age, Continuous(Years) | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W | Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 64.8 ± 11.18 | 72.0 ± 0 | 58.0 ± 0 | 72.0 ± 0 | 46.3 ± 25.42 | 61.2 ± 11.38 | 66.0 ± 6.99 | 59.0 ± 21.07 | 70.7 ± 1.15 | 59.0 ± 14.11 | 57.0 ± 19.80 | 65.9 ± 4.95 | 73.0 ± 1.41 | 70.7 ± 11.72 | 68.2 ± 8.11 | 61.56 ± 13.11 |
| Sex: Female, Male(Participants) | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W | Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 1 | 0 | 1 | 0 | 2 | 9 | 1 | 2 | 2 | 3 | 2 | 0 | 0 | 1 | 2 | 26 |
| Male | 3 | 1 | 0 | 1 | 1 | 4 | 5 | 1 | 1 | 4 | 0 | 7 | 2 | 2 | 4 | 36 |
| Race/Ethnicity, Customized(Participants) | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W | Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Race: Asian | 4 | 1 | 1 | 1 | 3 | 13 | 6 | 3 | 3 | 7 | 2 | 7 | 2 | 3 | 6 | 62 |
| Race/Ethnicity, Customized(Participants) | Part 1: E7130 25 mcg/m^2 Q2W | Part 1: E7130 50 mcg/m^2 Q2W | Part 1: E7130 100 mcg/m^2 Q2W | Part 1: E7130 200 mcg/m^2 Q2W | Part 1: E7130 300 mcg/m^2 Q2W | Part 1: E7130 350 mcg/m^2 Q2W | Part 1: E7130 400 mcg/m^2 Q2W | Part 1: E7130 270 mcg/m^2 Q3W | Part 1: E7130 410 mcg/m^2 Q3W | Part 1: E7130 480 mcg/m^2 Q3W | Part 1: E7130 550 mcg/m^2 Q3W | Part 2, SCCHN: E7130 410 mcg/m^2 Q3W | Part 2, SCCHN: 480 mcg/m^2 Q3W | Part 2, UC: E7130 410 mcg/m^2 Q3W | Part 2, UC: E7130 480 mcg/m^2 Q3W | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ethnicity — Non Hispanic or Latino | 4 | 1 | 1 | 1 | 3 | 13 | 6 | 3 | 3 | 7 | 2 | 7 | 2 | 3 | 6 | 62 |
PDFs hosted by the registry, ClinicalTrials.gov.
The trial was prematurely terminated due to the sponsor's decision.
The trial was prematurely terminated due to the sponsor's decision.
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