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This is an open-label, sequential dose escalation and expansion study to evaluate the safety, and pharmacokinetics of DS-5573a in Japanese patients with advanced solid malignant tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DS-5573a does escalation (step 1) and expansion (step 2) | Experimental | Step 1 of this study will follow a 3+3 study design with a starting intravenous (IV) dose of 0.1 mg/kg. Eight dose levels are planned, level 1: 0.1 mg/kg, level 1.5: 0.1 mg/kg, 0.3 mg/kg, level 2: 0.3 mg/kg, level 3: 1 mg/kg, level 4: 3 mg/kg, level 5: 10 mg/kg, level 6: 20 mg/kg, level 7: 30 mg/kg Step 2: 30 subjects will be enrolled and treated at the dose determined in Step 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-5573a | Drug | Step 1 of this study will use a starting intravenous (IV) dose of 0.1 mg/kg. Eight dose levels are planned, level 1: 0.1 mg/kg, level 1.5: 0.1 mg/kg, 0.3 mg/kg, level 2: 0.3 mg/kg, level 3: 1 mg/kg, level 4: 3 mg/kg, level 5: 10 mg/kg, level 6: 20 mg/kg, level 7: 30 mg/kg. Step 2: 30 subjects will use the dose determined in Step 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects experiencing dose limiting toxicities | Number of subjects experiencing dose limiting toxicities. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events. | Day 1 through Day 28 |
| Number of subjects experiencing adverse events | Number of subjects experiencing adverse events. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events. | Day 1 through 45 days after last dose |
| Pharmacokinetic profile of DS-5573a | Pharmacokinetic profile of DS-5573a. [Time Frame: Cycle 1, 2, 3: Days 1, 2, 4, 8,15; Cycle 4, 5, 6, 7, 8: Day 1] To assess the pharmacokinetic profile of DS-5573a in Japanese subjects with advanced malignant solid tumors. | Cycle 1 - Day 1 through Cycle 8 - Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of human anti-human antibodies (HAHA) against DS-5573a | Incidence of human anti-human antibodies (HAHA) against DS-5573a. | Cycle 1 - Day 1 through Cycle 1 - Day 15. |
| Assessment of tumor response to DS-5573a using RECIST ver1.1. |
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Inclusion Criteria:
Exclusion Criteria:
Cardiac failure (NYHA ≥ ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, uncontrolled deep-vein thrombosis or clinically severe thromboembolic event, or autoimmune disorders requiring treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Kenji Tamura, MD | National Cancer Center Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital | Tokyo | 104-0045 | Japan |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000613983 | DS-5573a |
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Assessment of tumor response is conducted every 6 weeks during the study until study end or the subject discontinues participation.
| week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 |
| Assessment of DS-5573a-related biomarkers in blood and tumor | Assessment of DS-5573a-related biomarkers in blood and tumor. | Cycle 1 - Days 1,2 through Cycle 3 - Days 1,2 |