A Phase 1 interventional study of DHES0815A in Breast Cancer, sponsored by Genentech, Inc.. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-05.
Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Phase 1, Interventional, and Treatment
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Among 229 studies in Breast Neoplasms by Hoffmann-La Roche — 16 open to participants now, 28 under way, 13 of them phase 3. Breast Neoplasms · Hoffmann-La Roche.
Among the 229 studies in Breast Neoplasms by Hoffmann-La Roche, this one is the 157th largest by enrollment of the 170 interventional ones that give a count, is one of 8 that started in 2018, is one of 27 in phase 1, and was the 183rd registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →16 of the 229 studies in Breast Neoplasms by Hoffmann-La Roche are open now, in 12 countries. Recruiting first, the newest first:
Hoffmann-La Roche · Sites in United States, Puerto Rico
Ages 18+
Hoffmann-La Roche · Sites in United States, Canada
Ages 18+
Genentech, Inc. · Sites in United States
Ages 18+ · Women only
Hoffmann-La Roche · Sites in United States, Argentina, Australia and 23 more countries
Ages 18+
Hoffmann-La Roche · Sites in United States, Argentina, Brazil and 9 more countries
Ages 18+
By country, each count listing its studies:
Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
229 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 38 · Phase 2 78 · Phase 3 63 · Phase 4 11
First in 1998; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 14 is below the median of 72 across 10,903 interventional studies indexed under Breast Neoplasms.
Median enrollment 151 across the 170 interventional studies, 276 across the 49 observational. Of the 193 that completed or were terminated, 120 (62%) have results posted.
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This study is registered under Genentech, Inc., one of the names counted as Hoffmann-La Roche. Under that name alone:
Genentech, Inc. is the lead sponsor of 517 studies on the registry; 20 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 52 (55%) have results posted.
6 of the studies in Breast Neoplasms by Hoffmann-La Roche that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04873362Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy | 2027-03-31 |
| NCT05894239Phase 3Hoffmann-La RocheA Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer | 2027-05-03 |
| NCT03006172Genentech, Inc.To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer | 2026-12-31 |
| NCT02568267Hoffmann-La RocheBasket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) | 2027-06-30 |
| NCT03332797Genentech, Inc.A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer | 2027-07-31 |
Add all 6 to your calendar (.ics) → With an account.
Among the 229 studies in Breast Neoplasms by Hoffmann-La Roche, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This first-in-human, Phase 1, open-label, multicenter, dose-escalation study will evaluate the safety, tolerability, and PK of DHES0815A as a single agent in participants with advanced and/or metastatic HER2-positive breast cancer for whom established treatment has proven ineffective or intolerable or is unavailable. The study may include a dose-expansion cohort (based on an ongoing assessment of the totality of data obtained in this study) to further assess safety, tolerability, PK, and preliminary anti-tumor activity.
Key Inclusion Criteria:
Key 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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on 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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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 share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
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.
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.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on 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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive DHES0815A in escalating doses in the dose-escalation cohort of the study. Participants will receive additional infusions of DHES0815A on Day 1 of subsequent cycles provided that they meet the protocol specified criteria for acceptable toxicity and ongoing clinical benefit.
Drug: DHES0815A
Participants will be treated at or below the Maximum Tolerated Dose (MTD) of DHES0815A (based on the review of the totality of the data) to obtain additional safety, tolerability, PK, and anti-tumor activity data.
Drug: DHES0815A
DHES0815A will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle.
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) With Severity Determined as Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. SAE is any AE that is fatal, is life threatening, requires or prolongs inpatient hospitalization, results in persistent/significant disability/incapacity and is congenital anomaly/birth defect. Severity of AEs were graded per NCI CTCAE v4.0. Grade 1: Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; or intervention not indicated; Grade 2: Moderate; minimal, local/non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3: Severe/medically significant, but not immediately life-threatening: hospitalization/prolongation of hospitalization indicated; disabling/limiting self-care activities of daily living; Grade 4: Life-threatening consequences/urgent intervention indicated; Grade 5: Death related to AE.
Time frame: From Day 1 to end of study (up to approximately 39 months)
Number of Participants With Dose-limiting Toxicity (DLT)
DLT=any one events occurring during DLT assessment window: ≥15% decrease from baseline in left ventricular ejection fraction (LVEF)/≥10% decrease to \<50% LVEF; Grade ≥ 3 non-hematologic toxicity; Grade ≥4 neutropenia (absolute neutrophil count \<500 cells/microliters \[μL\]) lasting \<7 days; Grade ≥3 febrile neutropenia; Grade ≥4 anemia; Grade ≥4 thrombocytopenia; Grade 3 thrombocytopenia associated with clinically significant bleeding; Any increase in hepatic transaminase (ALT or AST) \>3\*baseline in combination with either an increase in direct bilirubin \>2\*upper limit of normal/clinical jaundice, in absence of cholestasis/other contributory factors. NCI CTCAE v4.0. was used to grade these events.Grade1: Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; Grade2: Moderate; minimal, local/non-invasive intervention indicated;Grade3: Severe/medically significant, but not immediately life-threatening;Grade4: Life-threatening consequences/urgent intervention indicated.
Time frame: From Day 1 up to Day 21
Duration of Treatment
Treatment duration was calculated from the first dose of study drug to the last dose of study drug administration.
Time frame: From Day 1 up to last dose of study drug (up to approximately 39 months)
Total Cumulative Dose
Time frame: From Day 1 up to last dose of study drug (up to approximately 39 months)
Change From Baseline in LVEF as Assessed by Echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA) Scan
LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heartbeat and is a measure of cardiac output for the heart. Baseline LVEF value and the change from baseline to the worst value in LVEF measurement were reported. LVEF was measured by ECHO or MUGA scan.
Time frame: Baseline, end of Cycle 1, Days 15-21 of Cycles 2, 4, and 6, and every four cycles thereafter up to the study discontinuation visit (up to approximately 39 months)
Concentration of DHES0815A Total Antibody
DHES0815A total antibody is one of three key pharmacokinetic analytes of DHES0815A.
Time frame: Pre-dose and 30 minutes (min) post-dose on Day 1 Cycles 1-4; 4 hour (h) post-dose on Day 1 Cycle1; post-dose on Days 2, 3, 11, 17 Cycle 1; post-dose on Days 8 and 15 Cycles 1-4; study discontinuation visit (up to approx. 39 months) (Cycle length=21 days)
Concentration of Plasma Conjugated Pyrrolo [2,1-c] [1,4] Benzodiazepine Monoamide (PDB-MA)
Conjugated PDB-MA is one of three key pharmacokinetic analytes of DHES0815A.
Time frame: Pre-dose and 30 minutes (min) post-dose on Day 1 Cycles 1-4; 4 hour (h) post-dose on Day 1 Cycle1; post-dose on Days 2, 3, 11, 17 Cycle 1; post-dose on Days 8 and 15 Cycles 1-4; study discontinuation visit (up to approx. 39 months) (Cycle length=21 days)
Concentration of Plasma Unconjugated PDB-MA
Plasma Unconjugated PDB-MA is one of three key pharmacokinetic analytes of DHES0815A.
Time frame: Pre-dose and 30 minutes (min) post-dose on Day 1 Cycles 1-4; 4 hour (h) post-dose on Day 1 Cycle1; post-dose on Days 2, 3, 11, 17 Cycle 1; post-dose on Days 8 and 15 Cycles 1-4; study discontinuation visit (up to approx. 39 months) (Cycle length=21 days)
Number of Participants With Objective Response Assessed According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Objective response was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR, defined as disappearance of all target lesions. PR, defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR.
Time frame: From start of treatment until confirmation of CR or PR (up to approximately 39 months)
Duration of Response (DoR) Assessed According to RECIST v1.1
DOR was defined as the time from the first occurrence of a documented objective response to disease progression (PD) or death from any cause, whichever occurred first, as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Time frame: From the initial CR or PR to the time of PD or death, whichever occurs first (up to approximately 39 months)
Number of Participants With Anti-Drug Antibody (ADA) to DHES0815A
Number of participants with treatment induced and treatment-enhanced ADA are reported here. Participants were considered to have treatment-induced ADA responses if they were ADA negative at baseline and developed an ADA response following DHES0815A administration. Participants were considered to have treatment-enhanced ADA if they were ADA positive at baseline and the titer of one or more postbaseline samples is at least 4-fold greater than baseline titer (i.e., ≥ 0.60 titer units) following study drug administration.
Time frame: Pre-dose on Day 1 of Cycles 1-4 and 42 days after last infusion (up to approximately 39 months)
Participants took part in this study at 5 investigative sites in Republic of Korea and United States from 17 April 2018 to 16 July 2021.
| Milestone | Dose Escalation Cohort: DHES0815A 0.6 mg/kg | Dose Escalation Cohort: DHES0815A 1.2 mg/kg | Dose Escalation Cohort: DHES0815A 2.4 mg/kg | Dose Escalation Cohort: DHES0815A 4 mg/kg | Dose Escalation Cohort: DHES0815A 6 mg/kg |
|---|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 | 2 |
| Completed | 1 | 1 | 3 | 3 | 2 |
| Not completed | 2 | 2 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 | 0 | 0 |
AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. SAE is any AE that is fatal, is life threatening, requires or prolongs inpatient hospitalization, results in persistent/significant disability/incapacity and is congenital anomaly/birth defect. Severity of AEs were graded per NCI CTCAE v4.0. Grade 1: Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; or intervention not indicated; Grade 2: Moderate; minimal, local/non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3: Severe/medically significant, but not immediately life-threatening: hospitalization/prolongation of hospitalization indicated; disabling/limiting self-care activities of daily living; Grade 4: Life-threatening consequences/urgent intervention indicated; Grade 5: Death related to AE.
| Participants | Dose Escalation Cohort: DHES0815A 0.6 mg/kg | Dose Escalation Cohort: DHES0815A 1.2 mg/kg | Dose Escalation Cohort: DHES0815A 2.4 mg/kg | Dose Escalation Cohort: DHES0815A 4 mg/kg | Dose Escalation Cohort: DHES0815A 6 mg/kg |
|---|---|---|---|---|---|
| AEs | 3 | 3 | 3 | 3 | 2 |
| SAEs | 1 | 1 | 1 | 0 | 1 |
| Grade 1 AEs | 0 | 0 | 1 | 0 | 0 |
| Grade 2 AEs | 1 | 2 | 0 | 1 | 1 |
| Grade 3 AEs | 1 | 1 | 2 | 2 | 1 |
| Grade 4 AEs | 1 | 0 | 0 | 0 | 0 |
DLT=any one events occurring during DLT assessment window: ≥15% decrease from baseline in left ventricular ejection fraction (LVEF)/≥10% decrease to \<50% LVEF; Grade ≥ 3 non-hematologic toxicity; Grade ≥4 neutropenia (absolute neutrophil count \<500 cells/microliters \[μL\]) lasting \<7 days; Grade ≥3 febrile neutropenia; Grade ≥4 anemia; Grade ≥4 thrombocytopenia; Grade 3 thrombocytopenia associated with clinically significant bleeding; Any increase in hepatic transaminase (ALT or AST) \>3\*baseline in combination with either an increase in direct bilirubin \>2\*upper limit of normal/clinical jaundice, in absence of cholestasis/other contributory factors. NCI CTCAE v4.0. was used to grade these events.Grade1: Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; Grade2: Moderate; minimal, local/non-invasive intervention indicated;Grade3: Severe/medically significant, but not immediately life-threatening;Grade4: Life-threatening consequences/urgent intervention indicated.
| Participants | Dose Escalation Cohort: DHES0815A 0.6 mg/kg | Dose Escalation Cohort: DHES0815A 1.2 mg/kg | Dose Escalation Cohort: DHES0815A 2.4 mg/kg | Dose Escalation Cohort: DHES0815A 4 mg/kg | Dose Escalation Cohort: DHES0815A 6 mg/kg |
|---|---|---|---|---|---|
| Number of Participants With Dose-limiting Toxicity (DLT) | 0 | 0 | 0 | 0 | 0 |
Treatment duration was calculated from the first dose of study drug to the last dose of study drug administration.
| days | Dose Escalation Cohort: DHES0815A 0.6 mg/kg | Dose Escalation Cohort: DHES0815A 1.2 mg/kg | Dose Escalation Cohort: DHES0815A 2.4 mg/kg | Dose Escalation Cohort: DHES0815A 4 mg/kg | Dose Escalation Cohort: DHES0815A 6 mg/kg |
|---|---|---|---|---|---|
| Duration of Treatment | 64.0 (62 to 533) | 208.0 (85 to 960) | 43.0 (43 to 66) | 64.0 (64 to 127) | 43.0 (43 to 43) |
| milligrams (mg) | Dose Escalation Cohort: DHES0815A 0.6 mg/kg | Dose Escalation Cohort: DHES0815A 1.2 mg/kg | Dose Escalation Cohort: DHES0815A 2.4 mg/kg | Dose Escalation Cohort: DHES0815A 4 mg/kg | Dose Escalation Cohort: DHES0815A 6 mg/kg |
|---|---|---|---|---|---|
| Total Cumulative Dose | 882.33 ± 1355.91 | 2143.00 ± 2523.37 | 342.27 ± 157.78 | 1340.20 ± 586.56 | 548.80 ± 138.59 |
LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heartbeat and is a measure of cardiac output for the heart. Baseline LVEF value and the change from baseline to the worst value in LVEF measurement were reported. LVEF was measured by ECHO or MUGA scan.
| percentage points of LVEF | Dose Escalation Cohort: DHES0815A 0.6 mg/kg | Dose Escalation Cohort: DHES0815A 1.2 mg/kg | Dose Escalation Cohort: DHES0815A 2.4 mg/kg | Dose Escalation Cohort: DHES0815A 4 mg/kg | Dose Escalation Cohort: DHES0815A 6 mg/kg |
|---|---|---|---|---|---|
| Baseline | 59.00 ± 3.61 | 63.33 ± 4.04 | 64.00 ± 9.54 | 59.67 ± 0.58 | 62.50 ± 3.54 |
| Change From Baseline to Worst Value | 0.33 ± 4.04 | -1.67 ± 1.15 | -4.67 ± 7.77 | -1.33 ± 1.53 | -5.00 ± 0.00 |
DHES0815A total antibody is one of three key pharmacokinetic analytes of DHES0815A.
| nanograms per milliliters (ng/mL) | Dose Escalation Cohort: DHES0815A 0.6 mg/kg | Dose Escalation Cohort: DHES0815A 1.2 mg/kg | Dose Escalation Cohort: DHES0815A 2.4 mg/kg | Dose Escalation Cohort: DHES0815A 4 mg/kg | Dose Escalation Cohort: DHES0815A 6 mg/kg |
|---|---|---|---|---|---|
| Cycle 1 Day1: Predose | NA ± NA | NA ± NA | NA ± NA | NA ± NA | NA ± NA |
| Cycle 1 Day 1: 30 min Postdose | 13100 ± 27.2 | 48700 ± 29.0 | 49200 ± 27.3 | 88600 ± 11.4 | 119000 ± 0.0 |
| Cycle 1 Day 1: 4 h Postdose | 12200 ± 30.7 | 30500 ± 13.0 | 46900 ± 19.2 | 85900 ± 13.6 | 106000 ± 0.0 |
| Cycle 1 Day 2 | 8460 ± 34.9 | 27000 ± 18.7 | 35500 ± 46.5 | 69100 ± 13.2 | 96800 ± 11.6 |
| Cycle 1 Day 3 | 6330 ± 37.1 | 22000 ± 14.5 | 26600 ± 52.3 | 59700 ± 9.7 | 81100 ± 15.8 |
| Cycle 1 Day 8 | 625 ± 411.4 | 8120 ± 42.1 | 10700 ± 76.8 | 36000 ± 8.8 | 48000 ± 6.3 |
| Cycle 1 Day 11 | 225 ± NA | 4870 ± 34.2 | 6840 ± 90.1 | 26000 ± 5.1 | 42100 ± 26.7 |
| Cycle 1 Day 15 | 64.8 ± NA | 2160 ± 69.1 | 2100 ± 135.7 | 22800 ± 0.3 | 31300 ± 27.7 |
| Cycle 1 Day 17 | 50.0 ± NA | 1030 ± 190.3 | 981 ± 148.8 | 18800 ± 28.3 | 29700 ± 36.7 |
| Cycle 2 Day 1: Predose | 50.0 ± NA | 66.0 ± NA | 50.0 ± NA | 10500 ± 46.2 | 19900 ± 27.3 |
| Cycle 2 Day 1: 30 min Postdose | 11900 ± 29.6 | 33000 ± 28.8 | 30800 ± 101.0 | 97700 ± 15.8 | 85400 ± 62.2 |
| Cycle 2 Day 8 | 933 ± 165.1 | 9500 ± 11.1 | 10800 ± 46.2 | 44300 ± 8.5 | 80000 ± NA |
| Cycle 2 Day 15 | 50.0 ± NA | 2230 ± 37.2 | 1330 ± 78.7 | 27600 ± 12.9 | 31100 ± 123.0 |
| Cycle 3 Day 1: Predose | 50.0 ± NA | 50.00 ± NA | 50.0 ± NA | 18900 ± 38.9 | — |
| Cycle 3 Day 1: 30 min Postdose | 13600 ± 21.6 | 39300 ± 52.9 | 56900 ± NA | 119000 ± 14.1 | — |
| Cycle 3 Day 8 | 765 ± 921.0 | 9740 ± 19.7 | 8720 ± NA | 51900 ± 20.0 | — |
| Cycle 3 Day 15 | 50.0 ± NA | 2530 ± 66.3 | — | 30200 ± 24.7 | — |
| Cycle 4 Day 1: Predose | 50.0 ± NA | 65.8 ± NA | — | 13800 ± NA | — |
| Cycle 4 Day 1: 30 min Postdose | 8750 ± NA | 32800 ± 16.8 | — | 83900 ± NA | — |
| Cycle 4 Day 8 | 2130 ± NA | 11100 ± 23.5 | — | 24200 ± NA | — |
| Cycle 4 Day 15 | 50.0 ± NA | 3000 ± 72.6 | — | 13500 ± NA | — |
| Study Drug Discontinuation Visit | 231 ± NA | 483 ± NA | 75.5 ± NA | 50.0 ± NA | 27800 ± NA |
Conjugated PDB-MA is one of three key pharmacokinetic analytes of DHES0815A.
| ng/mL | Dose Escalation Cohort: DHES0815A 0.6 mg/kg | Dose Escalation Cohort: DHES0815A 1.2 mg/kg | Dose Escalation Cohort: DHES0815A 2.4 mg/kg | Dose Escalation Cohort: DHES0815A 4 mg/kg | Dose Escalation Cohort: DHES0815A 6 mg/kg |
|---|---|---|---|---|---|
| Cycle 1 Day1: Predose | NA ± NA | NA ± NA | NA ± NA | NA ± NA | NA ± NA |
| Cycle 1 Day 1: 30 min Postdose | 90.5 ± 23.4 | 242 ± 11.4 | 381 ± 28.0 | 702 ± 3.8 | 864 ± 4.4 |
| Cycle 1 Day 1: 4 h Postdose | 84.4 ± 28.9 | 234 ± 9.4 | 338 ± 31.0 | 666 ± 6.7 | 837 ± 4.6 |
| Cycle 1 Day 2 | 55.6 ± 32.8 | 186 ± 7.6 | 234 ± 44.6 | 508 ± 8.0 | 693 ± 5.4 |
| Cycle 1 Day 3 | 38.2 ± 32.5 | 147 ± 8.1 | 183 ± 48.4 | 440 ± 1.4 | 577 ± 12.9 |
| Cycle 1 Day 8 | 3.52 ± 394.8 | 53.8 ± 39.5 | 58.2 ± 69.4 | 225 ± 5.6 | 328 ± 5.2 |
| Cycle 1 Day 11 | 2.04 ± NA | 29.9 ± 33.7 | 33.0 ± 71.7 | 157 ± 6.4 | 259 ± 26.2 |
| Cycle 1 Day 15 | 0.947 ± NA | 11.6 ± 74.0 | 10.5 ± 122.9 | 118 ± 6.6 | 174 ± 28.4 |
| Cycle 1 Day 17 | 0.750 ± NA | 4.45 ± 313.1 | 4.40 ± 120.8 | 82.9 ± 29.5 | 160 ± 34.3 |
| Cycle 2 Day 1: Predose | 0.750 ± NA | 0.750 ± NA | 0.750 ± NA | 44.9 ± 59.5 | 90.6 ± 32.1 |
| Cycle 2 Day 1: 30 min Postdose | 92.8 ± 14.7 | 247 ± 19.4 | 232 ± 92.5 | 760 ± 10.4 | 636 ± 53.8 |
| Cycle 2 Day 8 | 5.01 ± 182.3 | 59.5 ± 14.7 | 30.9 ± 183.6 | 283 ± 11.5 | 451 ± NA |
| Cycle 2 Day 15 | 0.750 ± NA | 11.5 ± 35.6 | 3.25 ± 224.3 | 135 ± 16.3 | 324 ± NA |
| Cycle 3 Day 1: Predose | 0.750 ± NA | 0.750 ± NA | 0.750 ± NA | 76.3 ± 47.0 | — |
| Cycle 3 Day 1: 30 min Postdose | 100 ± 12.1 | 236 ± 17.5 | 381 ± NA | 803 ± 7.7 | — |
| Cycle 3 Day 8 | 3.63 ± NA | 57.9 ± 16.5 | 61.6 ± NA | 294 ± 20.7 | — |
| Cycle 3 Day 15 | 0.750 ± NA | 12.1 ± 53.9 | — | 143 ± 30.8 | — |
| Cycle 4 Day 1: Predose | 0.750 ± NA | 0.750 ± NA | — | 58.6 ± NA | — |
| Cycle 4 Day 1: 30 min Postdose | 112 ± NA | 244 ± 17.0 | — | 647 ± NA | — |
| Cycle 4 Day 8 | — | 55.8 ± 10.6 | — | 139 ± NA | — |
| Cycle 4 Day 15 | 0.750 ± NA | 13.8 ± 70.4 | — | — | — |
| Study Drug Discontinuation Visit | 0.750 ± NA | 3.93 ± NA | 1.38 ± NA | — | — |
Plasma Unconjugated PDB-MA is one of three key pharmacokinetic analytes of DHES0815A.
| ng/mL | Dose Escalation Cohort: DHES0815A 0.6 mg/kg | Dose Escalation Cohort: DHES0815A 1.2 mg/kg | Dose Escalation Cohort: DHES0815A 2.4 mg/kg | Dose Escalation Cohort: DHES0815A 4 mg/kg | Dose Escalation Cohort: DHES0815A 6 mg/kg |
|---|---|---|---|---|---|
| Cycle 1 Day1: Predose | NA ± NA | NA ± NA | NA ± NA | NA ± NA | NA ± NA |
| Cycle 1 Day 1: 30 min Postdose | 0.107 ± 14.4 | 0.362 ± 40.9 | 0.497 ± 47.1 | 0.772 ± 9.1 | 1.05 ± 5.4 |
| Cycle 1 Day 1: 4 h Postdose | 0.0770 ± 20.2 | 0.276 ± 16.9 | 0.328 ± 26.9 | 0.546 ± 21.4 | 0.985 ± 44.5 |
| Cycle 1 Day 2 | 0.0634 ± 27.8 | 0.175 ± 2.9 | 0.223 ± 72.6 | 0.449 ± 43.9 | 0.577 ± 18.5 |
| Cycle 1 Day 3 | 0.0568 ± 31.8 | 0.130 ± 21.8 | 0.179 ± 40.2 | 0.252 ± 24.7 | 0.332 ± 14.5 |
| Cycle 1 Day 8 | 0.0300 ± 6.1 | 0.0800 ± 15.0 | 0.0927 ± 25.0 | 0.185 ± 32.4 | 0.163 ± 37.7 |
| Cycle 1 Day 11 | 0.0172 ± NA | 0.0605 ± 16.8 | 0.0806 ± 15.2 | 0.146 ± 54.3 | 0.170 ± 43.2 |
| Cycle 1 Day 15 | 0.0120 ± NA | 0.0405 ± 19.7 | 0.0490 ± 48.5 | 0.110 ± 47.6 | 0.103 ± 4.9 |
| Cycle 1 Day 17 | 0.0120 ± NA | 0.0337 ± 16.2 | 0.0389 ± 54.4 | 0.0896 ± 40.4 | 0.101 ± 37.4 |
| Cycle 2 Day 1: Predose | 0.0120 ± NA | 0.0120 ± NA | 0.0178 ± NA | 0.0836 ± 69.5 | 0.0991 ± 60.4 |
| Cycle 2 Day 1: 30 min Postdose | 0.0969 ± 16.4 | 0.324 ± 29.7 | 0.321 ± 73.3 | 0.953 ± 17.6 | 0.693 ± 76.5 |
| Cycle 2 Day 8 | 0.0306 ± 14.3 | 0.0846 ± 19.3 | 0.0662 ± 68.0 | 0.214 ± 51.4 | 0.196 ± NA |
| Cycle 2 Day 15 | 0.0120 ± NA | 0.0435 ± 8.1 | 0.0266 ± 96.3 | 0.164 ± 30.7 | 0.149 ± 45.0 |
| Cycle 3 Day 1: Predose | 0.0120 ± NA | 0.0120 ± NA | 0.0120 ± NA | 0.144 ± 49.1 | — |
| Cycle 3 Day 1: 30 min Postdose | 0.132 ± 20.5 | 0.327 ± 33.4 | 0.716 ± NA | 1.09 ± 10.3 | — |
| Cycle 3 Day 8 | 0.0314 ± 0.7 | 0.0785 ± 16.4 | 0.102 ± NA | 0.236 ± 41.1 | — |
| Cycle 3 Day 15 | 0.0120 ± NA | 0.0510 ± 14.4 | — | 0.181 ± 40.1 | — |
| Cycle 4 Day 1: Predose | 0.0120 ± NA | 0.0120 ± 23.9 | — | 0.0938 ± NA | — |
| Cycle 4 Day 1: 30 min Postdose | 0.0570 ± NA | 0.338 ± 23.9 | — | 0.633 ± NA | — |
| Cycle 4 Day 8 | 0.0316 ± NA | 0.108 ± 19.1 | — | 0.149 ± NA | — |
| Cycle 4 Day 15 | 0.0120 ± NA | 0.0574 ± 17.3 | — | 0.0906 ± NA | — |
| Study Drug Discontinuation Visit | 0.0226 ± NA | 0.0452 ± 56.1 | 0.0249 ± 71.8 | 0.0120 ± NA | 0.0374 ± NA |
Objective response was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR, defined as disappearance of all target lesions. PR, defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR.
| Participants | Dose Escalation Cohort: DHES0815A 0.6 mg/kg | Dose Escalation Cohort: DHES0815A 1.2 mg/kg | Dose Escalation Cohort: DHES0815A 2.4 mg/kg | Dose Escalation Cohort: DHES0815A 4 mg/kg | Dose Escalation Cohort: DHES0815A 6 mg/kg |
|---|---|---|---|---|---|
| Complete Response (CR) | 0 | 1 | 0 | 0 | 0 |
| Partial Response (PR) | 0 | 0 | 0 | 0 | 0 |
DOR was defined as the time from the first occurrence of a documented objective response to disease progression (PD) or death from any cause, whichever occurred first, as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
| months | Dose Escalation Cohort: DHES0815A 0.6 mg/kg | Dose Escalation Cohort: DHES0815A 1.2 mg/kg | Dose Escalation Cohort: DHES0815A 2.4 mg/kg | Dose Escalation Cohort: DHES0815A 4 mg/kg | Dose Escalation Cohort: DHES0815A 6 mg/kg |
|---|---|---|---|---|---|
| Duration of Response (DoR) Assessed According to RECIST v1.1 | — | NA (NA to NA) | — | — | — |
Number of participants with treatment induced and treatment-enhanced ADA are reported here. Participants were considered to have treatment-induced ADA responses if they were ADA negative at baseline and developed an ADA response following DHES0815A administration. Participants were considered to have treatment-enhanced ADA if they were ADA positive at baseline and the titer of one or more postbaseline samples is at least 4-fold greater than baseline titer (i.e., ≥ 0.60 titer units) following study drug administration.
| Participants | Dose Escalation Cohort: DHES0815A 0.6 mg/kg | Dose Escalation Cohort: DHES0815A 1.2 mg/kg | Dose Escalation Cohort: DHES0815A 2.4 mg/kg | Dose Escalation Cohort: DHES0815A 4 mg/kg | Dose Escalation Cohort: DHES0815A 6 mg/kg |
|---|---|---|---|---|---|
| Baseline: ADA Positive | 1 | 0 | 0 | 0 | 1 |
| Post-baseline: Treatment-induced ADA Positive | 0 | 1 | 1 | 0 | 0 |
| Post-baseline: Treatment-enhanced ADA Positive | 0 | 0 | 0 | 0 | 0 |
Collected over From Day 1 to end of study (up to approximately 39 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dose Escalation Cohort: DHES0815A 0.6 mg/kg | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| Dose Escalation Cohort: DHES0815A 1.2 mg/kg | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| Dose Escalation Cohort: DHES0815A 2.4 mg/kg | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| Dose Escalation Cohort: DHES0815A 4 mg/kg | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Dose Escalation Cohort: DHES0815A 6 mg/kg | 0/2 (0%) | 1/2 (50%) | 2/2 (100%) |
| Event | Dose Escalation Cohort: DHES0815A 0.6 mg/kg | Dose Escalation Cohort: DHES0815A 1.2 mg/kg | Dose Escalation Cohort: DHES0815A 2.4 mg/kg | Dose Escalation Cohort: DHES0815A 4 mg/kg | Dose Escalation Cohort: DHES0815A 6 mg/kg |
|---|---|---|---|---|---|
| HeadacheNervous system disorders | 0/3 | 0/3 | 0/3 | 0/3 | 1/2 |
| BradycardiaCardiac disorders | 1/3 | 0/3 | 0/3 | 0/3 | 0/2 |
| AppendicitisInfections and infestations | 0/3 | 1/3 | 0/3 | 0/3 | 0/2 |
| PneumoniaInfections and infestations | 1/3 | 0/3 | 0/3 | 0/3 | 0/2 |
| Acute kidney injuryRenal and urinary disorders | 0/3 | 0/3 | 1/3 | 0/3 | 0/2 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/3 | 0/3 | 0/3 | 0/3 | 0/2 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 1/3 | 0/3 | 0/3 | 0/3 | 0/2 |
| ThrombosisVascular disorders | 1/3 | 0/3 | 0/3 | 0/3 | 0/2 |
| Event | Dose Escalation Cohort: DHES0815A 0.6 mg/kg | Dose Escalation Cohort: DHES0815A 1.2 mg/kg | Dose Escalation Cohort: DHES0815A 2.4 mg/kg | Dose Escalation Cohort: DHES0815A 4 mg/kg | Dose Escalation Cohort: DHES0815A 6 mg/kg |
|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 0/3 | 0/3 | 0/3 | 0/3 | 2/2 |
| FatigueGeneral disorders | 0/3 | 1/3 | 2/3 | 1/3 | 2/2 |
| PruritusSkin and subcutaneous tissue disorders | 0/3 | 1/3 | 0/3 | 3/3 | 1/2 |
| AnaemiaBlood and lymphatic system disorders | 2/3 | 1/3 | 1/3 | 0/3 | 0/2 |
| PhotophobiaEye disorders | 0/3 | 0/3 | 0/3 | 2/3 | 1/2 |
| NauseaGastrointestinal disorders | 0/3 | 0/3 | 2/3 | 1/3 | 1/2 |
| Alanine aminotransferase increasedInvestigations | 0/3 | 2/3 | 0/3 | 0/3 | 0/2 |
| Aspartate aminotransferase increasedInvestigations | 0/3 | 2/3 | 0/3 | 0/3 | 0/2 |
| Blood alkaline phosphatase increasedInvestigations | 1/3 | 2/3 | 0/3 | 0/3 | 1/2 |
| HeadacheNervous system disorders | 1/3 | 0/3 | 0/3 | 2/3 | 1/2 |
Safety evaluable population included all enrolled participants who received at least one dose of study medication.
| Age, Continuous(years) | Dose Escalation Cohort: DHES0815A 0.6 mg/kg | Dose Escalation Cohort: DHES0815A 1.2 mg/kg | Dose Escalation Cohort: DHES0815A 2.4 mg/kg | Dose Escalation Cohort: DHES0815A 4 mg/kg | Dose Escalation Cohort: DHES0815A 6 mg/kg | Total |
|---|---|---|---|---|---|---|
| Mean | 64.3 ± 6.1 | 58.3 ± 4.5 | 49.3 ± 8.3 | 48.3 ± 5.0 | 50.0 ± 15.6 | 54.4 ± 9.3 |
| Sex: Female, Male(Participants) | Dose Escalation Cohort: DHES0815A 0.6 mg/kg | Dose Escalation Cohort: DHES0815A 1.2 mg/kg | Dose Escalation Cohort: DHES0815A 2.4 mg/kg | Dose Escalation Cohort: DHES0815A 4 mg/kg | Dose Escalation Cohort: DHES0815A 6 mg/kg | Total |
|---|---|---|---|---|---|---|
| Female | 3 | 3 | 3 | 3 | 2 | 14 |
| Male | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Dose Escalation Cohort: DHES0815A 0.6 mg/kg | Dose Escalation Cohort: DHES0815A 1.2 mg/kg | Dose Escalation Cohort: DHES0815A 2.4 mg/kg | Dose Escalation Cohort: DHES0815A 4 mg/kg | Dose Escalation Cohort: DHES0815A 6 mg/kg | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 3 | 3 | 2 | 3 | 2 | 13 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Dose Escalation Cohort: DHES0815A 0.6 mg/kg | Dose Escalation Cohort: DHES0815A 1.2 mg/kg | Dose Escalation Cohort: DHES0815A 2.4 mg/kg | Dose Escalation Cohort: DHES0815A 4 mg/kg | Dose Escalation Cohort: DHES0815A 6 mg/kg | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 0 | 0 | 1 |
| Asian | 0 | 1 | 1 | 1 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 0 | 0 | 1 |
| White | 2 | 2 | 1 | 2 | 2 | 9 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2018 to primary completion in Jul 2021, 38 months.
Results were first posted in Aug 2024, 3 years after primary completion.
Of 389 industry-sponsored phase 1 interventional studies under Breast Neoplasms, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 56. This study's 38 months is close to that.
Counting every sponsor, half of 761 studies reached it within 44 months; a quarter within 25 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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