A Phase 1/2 interventional study of DSP-0509 and DSP-0509, Pembrolizumab in Neoplasms, sponsored by Sumitomo Pharma America, Inc.. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-30.
Sponsored by Sumitomo Pharma America, Inc. (part of Sumitomo Pharma Co., Ltd.) · Phase 1/2, Interventional, and Treatment
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This is a multi-center, Phase 1 / 2 clinical study for patients with advanced solid tumors. The study consists of 2 treatment arms - a monotherapy arm and a combination arm. The monotherapy arm has 1 part: Dose Escalation (Part A). The combination arm has Dose Escalation (Part B) only.
The primary objective of Monotherapy Arm A is to determine the MTD or RP2D of DSP-0509 when administered as a single agent. Approximately 21 to 30 patients with advanced solid tumors will be enrolled. Several provisional dose levels of DSP-0509, with approximately 3 to 6 patients at each level may be tested in patients with advanced solid tumors. DSP-0509 will be administered as a single agent q2w beginning on Day 1.
The primary objective of Combination Therapy Arm B is to determine the RP2D of DSP-0509 when administered in combination with pembrolizumab, using a BLRM approach. The combination arm will enroll approximately 21 to 30 patients with advanced solid tumors that are (a) metastatic or unresectable and recurrent, and/or refractory to available therapy, (b) a condition for which pembrolizumab is an approved treatment, and (c) in patients who have shown either primary or acquired resistance to an ICI. DSP-0509 will be administered on Day 1 and then every 2 weeks thereafter. Pembrolizumab will be initiated on Day 1.
The primary objective of Combination Therapy Arm C is to determine preliminary efficacy in the form of the ORR of DSP-0509 when administered in combination with pembrolizumab to an expansion cohort of patients with HNSCC, using a Bayesian Adaptive design approach. Combination Arm C will enroll approximately 20 to 40 patients with HNSCC tumors that are (a) metastatic or unresectable, and recurrent and/or refractory to available therapy, (b) in patients who have been treated with pembrolizumab or other PD-1 or PD-L1 inhibitors in monotherapy, and (c) who have subsequently shown either primary or acquired resistance to ICIs.
Dose escalation of DSP-0509 in combination with 400 mg pembrolizumab q6w will start at the same dose of DSP-0509 as the highest (not exceeding the MTD) level tested in the combination regimen with 200 mg pembrolizumab q3w. Upon completion of the DLT evaluation period for the first DSP-0509 dose level tested in combination with 400 mg pembrolizumab q6w in newly enrolled patients, if this dose level is found not to exceed the MTD, any ongoing patients receiving DSP-0509 in combination with pembrolizumab 200 mg q3w will be allowed, at the investigator's discretion, to transition to the 400 mg pembrolizumab q6w regimen, while maintaining the originally assigned DSP-0509 dose level.
10,824 studies on the registry are indexed under Neoplasms; 2,325 are open to participants now.
This study's enrollment of 36 is below the median of 60 across 7,706 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Sumitomo Pharma America, Inc. is the lead sponsor of 181 studies on the registry; 5 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 21 (64%) have results posted.
First submitted after Sumitomo Pharma America, Inc. became part of Sumitomo Pharma Co., Ltd..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must fulfill each of the following requirements:
Combination Arm C (Dose Expansion), Phase 2 - Advanced HNSCC tumors of the oropharynx, oral cavity, hypopharynx, larynx, lip, or sinus that are (a) metastatic or unresectable, and recurrent and/or refractory to available therapy, (b) in patients who have been treated with pembrolizumab or other PD-1 or PD-L1 inhibitors in monotherapy, and (c) who have subsequently shown primary or acquired resistance to ICIs.
For enrollment in both arms:
a. Prothrombin \< 1.5. b. Partial thromboplastin time \< 1.5 times the (ULN).
a. White blood cell (WBC) count ≥ 3,000/microliter. b. (ANC) ≥ 1,500/microliter (patient may not use granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor to achieve these WBC and ANC levels).
c. count ≥ 100 × 103/microliter. d. (Hgb) ≥ 9.0 g/dL (may not transfuse or use erythropoietin to obtain this Hgb level).
Alanine aminotransferase ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver metastases).
In addition to the above criteria, patients must meet the following criteria to be eligible to enroll in Combination Arm C:
Exclusion Criteria:
Patients with any of the following will be excluded from the study:
For enrollment in both arms:
The following exclusion applies only to enrollment in Combination arms Part B \& C:
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
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.
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.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
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.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
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.
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.
Dose Escalation Drug DSP-0509
Drug: DSP-0509
Dose Escalation Drug DSP-0509, Pembrolizumab
Drug: DSP-0509, Pembrolizumab
Dose Expansion, Drug DSP-0509, Pembrolizumab
Drug: DSP-0509, Pembrolizumab
Each patient treated will receive DSP-0509 at the dose fixed for that Part or cohort administered as a constant rate IV infusion over 10 minutes using a syringe pump.
Drug page: Pembrolizumab
Each patient treated will receive DSP-0509 at the dose fixed for that Part or cohort administered as a constant rate IV infusion over 10 minutes using a syringe pump and is given in combination with pembrolizumab which should be administered following the dosing schedule of the approved label (200 mg IV q3w)
Drug page: Pembrolizumab
Each patient treated will receive DSP-0509 at the Recommended Phase II Dose (RP2D) level as determined in Part B. It is given as a constant rate IV infusion over 10 minutes using a syringe pump and is given in combination with pembrolizumab which should be administered following the dosing schedule of the approved label (400 mg IV q6w)
Number of Participants With Dose-limiting Toxicities (DLTs) Within the First 6 Weeks of Dosing
Time frame: From the time of first dose to 6 weeks after the first dose
Determination of the Recommended Phase 2 Dose (RP2D) by Assessing Dose-limiting Toxicities (DLTs)
Time frame: 28 days
Determination of the MTD of DSP-0509 When Given in Combination With Pembrolizumab by Assessing Dose-limiting Toxicities (DLTs).
MTD of DSP-0509 in patients enrolled into the Combination Arm during the dose escalation part of the study.
Time frame: 28 days
Determination of RP2D of DSP-0509 When Given in Combination With Pembrolizumab by Assessing DLTs
Data to be derived from patients enrolled into the Combination Arm - Part B (Phase 1).
Time frame: 28 days
Preliminary Antitumor Activity of DSP-0509 in Combination With Pembrolizumab in Patients With Head & Neck Squamous Cell Carcinoma (HNSCC) Who Have Shown Primary or Acquired Resistance to Immune Checkpoint Inhibitors (ICIs)
Data to be derived from patients enrolled into the Combination Arm - Part C (Phase 2)
Time frame: 4 weeks
Evaluate Pharmacokinetics (PK) for Single Agent DSP-0509 by Assessing Plasma Concentration.
Data to be derived from patients enrolled into the Monotherapy Arm - Part A (Phase 1)
Time frame: 8 weeks
Objective Response Rate (ORR) by RECIST
Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: From date of first dose to 6 months post first dose
ORR by Immune RECIST (iRECIST)
Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on iRECIST.
Time frame: From date of first dose to 6 months post first dose
Duration of Response (DoR) by RECIST
Defined as the time from first documentation of response until the time of first documentation of disease progression by RECIST v1.1.
Time frame: 6 months
DoR by iRECIST
Defined as the time from first documentation of response until the time of first documentation of disease progression by iRECIST.
Time frame: 6 months
Progression Free Survival (PFS) by RECIST
Defined as the time from first dose to the earlier date of assessment of progression or death by any cause in the absence of progression by RECIST v1.1.
Time frame: 12 months
PFS by iRECIST
Defined as the time from first dose to the earlier date of assessment of progression or death by any cause in the absence of progression by iRECIST.
Time frame: 12 months
Evaluate Single Agent DSP-0509-induced Changes in Cytokine Levels.
Data to be derived from patients enrolled into the Monotherapy Arm - Part A (Phase 1)
Time frame: 8 weeks
Evaluate Change in Cytokine Levels Induced by DSP-0509 in Combination With Pembrolizumab.
Data to be derived from patients enrolled into the Combination Arm - Part B (Phase 1)
Time frame: 8 weeks
Evaluate Pharmacokinetics (PK) for Combo Agents DSP-0509 and Pembrolizumab by Assessing Plasma Concentration.
Data to be derived from patients enrolled into the Combination Arm - Part B (Phase 1)
Time frame: 8 weeks
Identification of Potential Metabolites of DSP-0509 in Plasma and Possibly in Urine.
Data to be derived from patients enrolled into the Monotherapy Arm - Part A (Phase 1)
Time frame: 8 weeks
Exploratory Pharmacodynamic Evaluation as Potential Biomarkers Capable of Predicting the Clinical Efficacy or Toxicity
Time frame: 12 months
Exploratory Pharmacodynamic Evaluation as Potential Efficacy-related Immune Response Biomarkers.
Time frame: 12 months
Evaluate the Effect of DSP-0509 on Cardiac Parameters by Assessing Continuous 25-hour ECG Recordings.
Data to be derived from patients enrolled into Monotherapy Arm - Part A (Phase 1)
Time frame: 12 months
Evaluate the PFS Rate as a Potential Evaluation of Treatment Benefit of DSP-0509 Administered With Pembrolizumab
Data to be derived from patients enrolled into Combination Arm - Part C (Phase 2)
Time frame: 12 months
Thirty-six patients were enrolled into the Phase 1 (dose escalation) portion of this study. The study was terminated due to Sponsor's considerations, and therefore the MTD and RP2D have not been determined. No patients were enrolled into the Phase 2 (dose expansion) portion of the study.
| Milestone | Monotherapy Arm - Cohort 1 | Monotherapy Arm - Cohort 2 | Monotherapy Arm - Cohort 3 | Monotherapy Arm - Cohort 4 | Monotherapy Arm - Cohort 5 | Monotherapy Arm - Cohort 6 | Combination Arm - Cohort 1 | Combination Arm - Cohort 2 | Combination Arm - Cohort 3 | Combination Arm - Cohort 4 |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 3 | 4 | 5 | 3 | 4 | 7 | 1 | 3 | 3 | 3 |
| Completed | 3 | 4 | 5 | 3 | 4 | 7 | 1 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Participants | Monotherapy Arm - Cohort 1 | Monotherapy Arm - Cohort 2 | Monotherapy Arm - Cohort 3 | Monotherapy Arm - Cohort 4 | Monotherapy Arm - Cohort 5 | Monotherapy Arm - Cohort 6 | Combination Arm - Cohort 1 | Combination Arm - Cohort 2 | Combination Arm - Cohort 3 | Combination Arm - Cohort 4 |
|---|---|---|---|---|---|---|---|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLTs) Within the First 6 Weeks of Dosing | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
No measurements were reported for this outcome.
MTD of DSP-0509 in patients enrolled into the Combination Arm during the dose escalation part of the study.
No measurements were reported for this outcome.
Data to be derived from patients enrolled into the Combination Arm - Part B (Phase 1).
No measurements were reported for this outcome.
Data to be derived from patients enrolled into the Combination Arm - Part C (Phase 2)
No measurements were reported for this outcome.
Data to be derived from patients enrolled into the Monotherapy Arm - Part A (Phase 1)
No measurements were reported for this outcome.
Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
No measurements were reported for this outcome.
Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on iRECIST.
No measurements were reported for this outcome.
Defined as the time from first documentation of response until the time of first documentation of disease progression by RECIST v1.1.
No measurements were reported for this outcome.
Defined as the time from first documentation of response until the time of first documentation of disease progression by iRECIST.
No measurements were reported for this outcome.
Defined as the time from first dose to the earlier date of assessment of progression or death by any cause in the absence of progression by RECIST v1.1.
No measurements were reported for this outcome.
Defined as the time from first dose to the earlier date of assessment of progression or death by any cause in the absence of progression by iRECIST.
No measurements were reported for this outcome.
Data to be derived from patients enrolled into the Monotherapy Arm - Part A (Phase 1)
No measurements were reported for this outcome.
Data to be derived from patients enrolled into the Combination Arm - Part B (Phase 1)
No measurements were reported for this outcome.
Data to be derived from patients enrolled into the Combination Arm - Part B (Phase 1)
No measurements were reported for this outcome.
Data to be derived from patients enrolled into the Monotherapy Arm - Part A (Phase 1)
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Data to be derived from patients enrolled into Monotherapy Arm - Part A (Phase 1)
No measurements were reported for this outcome.
Data to be derived from patients enrolled into Combination Arm - Part C (Phase 2)
No measurements were reported for this outcome.
Collected over Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, an average of 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Monotherapy Arm - Cohort 1 | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Monotherapy Arm - Cohort 2 | 0/4 (0%) | 2/4 (50%) | 4/4 (100%) |
| Monotherapy Arm - Cohort 3 | 1/5 (20%) | 2/5 (40%) | 5/5 (100%) |
| Monotherapy Arm - Cohort 4 | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| Monotherapy Arm - Cohort 5 | 1/4 (25%) | 1/4 (25%) | 4/4 (100%) |
| Monotherapy Arm - Cohort 6 | 1/7 (14.3%) | 3/7 (42.9%) | 7/7 (100%) |
| Combination Arm - Cohort 1 | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| Combination Arm - Cohort 2 | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| Combination Arm - Cohort 3 | 0/3 (0%) | 2/3 (66.7%) | 3/3 (100%) |
| Combination Arm - Cohort 4 | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Event | Monotherapy Arm - Cohort 1 | Monotherapy Arm - Cohort 2 | Monotherapy Arm - Cohort 3 | Monotherapy Arm - Cohort 4 | Monotherapy Arm - Cohort 5 | Monotherapy Arm - Cohort 6 | Combination Arm - Cohort 1 | Combination Arm - Cohort 2 | Combination Arm - Cohort 3 | Combination Arm - Cohort 4 |
|---|---|---|---|---|---|---|---|---|---|---|
| UveitisEye disorders | 0/3 | 0/4 | 0/5 | 0/3 | 0/4 | 0/7 | 1/1 | 0/3 | 0/3 | 0/3 |
| AnaemiaBlood and lymphatic system disorders | 0/3 | 0/4 | 0/5 | 1/3 | 0/4 | 1/7 | 0/1 | 0/3 | 0/3 | 0/3 |
| HypoacusisEar and labyrinth disorders | 0/3 | 0/4 | 0/5 | 0/3 | 0/4 | 0/7 | 0/1 | 0/3 | 1/3 | 0/3 |
| Fluid overloadMetabolism and nutrition disorders | 0/3 | 0/4 | 0/5 | 0/3 | 0/4 | 0/7 | 0/1 | 1/3 | 0/3 | 0/3 |
| Back painMusculoskeletal and connective tissue disorders | 0/3 | 0/4 | 0/5 | 1/3 | 0/4 | 0/7 | 0/1 | 0/3 | 0/3 | 0/3 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/3 | 0/4 | 0/5 | 0/3 | 0/4 | 0/7 | 0/1 | 1/3 | 0/3 | 0/3 |
| ThrombophlebitisVascular disorders | 0/3 | 0/4 | 0/5 | 0/3 | 0/4 | 0/7 | 0/1 | 0/3 | 1/3 | 0/3 |
| NauseaGastrointestinal disorders | 0/3 | 1/4 | 0/5 | 0/3 | 0/4 | 1/7 | 0/1 | 0/3 | 0/3 | 0/3 |
| Disease progressionGeneral disorders | 0/3 | 0/4 | 1/5 | 0/3 | 1/4 | 0/7 | 0/1 | 0/3 | 0/3 | 0/3 |
| Multiple organ dysfunction syndromeGeneral disorders | 0/3 | 0/4 | 0/5 | 0/3 | 1/4 | 0/7 | 0/1 | 0/3 | 0/3 | 0/3 |
| Event | Monotherapy Arm - Cohort 1 | Monotherapy Arm - Cohort 2 | Monotherapy Arm - Cohort 3 | Monotherapy Arm - Cohort 4 | Monotherapy Arm - Cohort 5 | Monotherapy Arm - Cohort 6 | Combination Arm - Cohort 1 | Combination Arm - Cohort 2 | Combination Arm - Cohort 3 | Combination Arm - Cohort 4 |
|---|---|---|---|---|---|---|---|---|---|---|
| Lymph node painBlood and lymphatic system disorders | 0/3 | 1/4 | 0/5 | 0/3 | 0/4 | 0/7 | 1/1 | 0/3 | 0/3 | 0/3 |
| Blurred visionEye disorders | 0/3 | 0/4 | 0/5 | 0/3 | 1/4 | 0/7 | 1/1 | 0/3 | 0/3 | 0/3 |
| Eye painEye disorders | 0/3 | 0/4 | 0/5 | 0/3 | 0/4 | 0/7 | 1/1 | 0/3 | 0/3 | 0/3 |
| UveitisEye disorders | 0/3 | 0/4 | 0/5 | 0/3 | 0/4 | 0/7 | 1/1 | 0/3 | 0/3 | 0/3 |
| Abdominal painGastrointestinal disorders | 0/3 | 0/4 | 2/5 | 0/3 | 0/4 | 0/7 | 1/1 | 0/3 | 0/3 | 0/3 |
| Dry mouthGastrointestinal disorders | 0/3 | 0/4 | 0/5 | 0/3 | 1/4 | 0/7 | 1/1 | 0/3 | 0/3 | 1/3 |
| FatigueGeneral disorders | 2/3 | 1/4 | 3/5 | 2/3 | 3/4 | 2/7 | 1/1 | 1/3 | 1/3 | 2/3 |
| Facial painGeneral disorders | 0/3 | 0/4 | 0/5 | 0/3 | 0/4 | 0/7 | 1/1 | 0/3 | 0/3 | 0/3 |
| Aspartate aminotransferase increasedInvestigations | 0/3 | 0/4 | 0/5 | 1/3 | 0/4 | 0/7 | 1/1 | 0/3 | 0/3 | 1/3 |
| Alanine aminotransferase increasedInvestigations | 0/3 | 0/4 | 0/5 | 0/3 | 0/4 | 0/7 | 1/1 | 0/3 | 0/3 | 0/3 |
| Age, Categorical(Participants) | Monotherapy Arm - Cohort 1 | Monotherapy Arm - Cohort 2 | Monotherapy Arm - Cohort 3 | Monotherapy Arm - Cohort 4 | Monotherapy Arm - Cohort 5 | Monotherapy Arm - Cohort 6 | Combination Arm - Cohort 1 | Combination Arm - Cohort 2 | Combination Arm - Cohort 3 | Combination Arm - Cohort 4 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 3 | 3 | 2 | 2 | 6 | 1 | 1 | 3 | 2 | 26 |
| >=65 years | 0 | 1 | 2 | 1 | 2 | 1 | 0 | 2 | 0 | 1 | 10 |
| Sex: Female, Male(Participants) | Monotherapy Arm - Cohort 1 | Monotherapy Arm - Cohort 2 | Monotherapy Arm - Cohort 3 | Monotherapy Arm - Cohort 4 | Monotherapy Arm - Cohort 5 | Monotherapy Arm - Cohort 6 | Combination Arm - Cohort 1 | Combination Arm - Cohort 2 | Combination Arm - Cohort 3 | Combination Arm - Cohort 4 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 1 | 1 | 1 | 1 | 2 | 4 | 0 | 2 | 2 | 2 | 16 |
| Male | 2 | 3 | 4 | 2 | 2 | 3 | 1 | 1 | 1 | 1 | 20 |
| Race (NIH/OMB)(Participants) | Monotherapy Arm - Cohort 1 | Monotherapy Arm - Cohort 2 | Monotherapy Arm - Cohort 3 | Monotherapy Arm - Cohort 4 | Monotherapy Arm - Cohort 5 | Monotherapy Arm - Cohort 6 | Combination Arm - Cohort 1 | Combination Arm - Cohort 2 | Combination Arm - Cohort 3 | Combination Arm - Cohort 4 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 6 |
| White | 2 | 3 | 3 | 3 | 4 | 5 | 1 | 2 | 3 | 3 | 29 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2018 to primary completion in Dec 2022, 54 months.
Results were first posted in May 2024, 1 year 5 months after primary completion.
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Studies of the drug tested here: Pembrolizumab
Sumitomo Pharma America, Inc. →