Open Label Study of DS-5573a

Study Overview
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Brief Summary
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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.

Official Title
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Phase 1, Open Label Study to Assess the Safety and Pharmacokinetics of DS-5573a in Japanese Patients With Advanced Solid Malignant Tumors

Conditions
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Advanced Solid Malignant Tumors

Intervention / Treatment
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* Drug: DS-5573a


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available. Eastern Cooperative Oncology Group performance status(PS) of 0 or 1 Exclusion Criteria: Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment: 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. Severe or uncontrolled concomitant disease. Clinically active brain metastases defined as symptomatic or requiring treatment.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DS-5573a does escalation (step 1) and expansion (step 2)<br>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. | Drug: DS-5573a<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced solid malignant tumor, phase 1, oncology