Study of DS-1123a in Advanced Solid Tumours

Study Overview
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Brief Summary
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This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of DS-1123a in Japanese subjects with advanced solid tumors.

Official Title
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Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-1123a in Subjects With Advanced Solid Tumors

Conditions
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Advanced Solid Malignant Tumors

Intervention / Treatment
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* Drug: DS-1123


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, deep-vein thrombosis or clinically severe thromboembolic event, or clinically severe pulmonary disease (eg, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, drug induced pneumonia), 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-1123<br>This study will follow a modified Continual Reassessment Method (mCRM) + Escalation with Overdose Control (EWOC),design with a starting intravenous (IV) dose of 0.1 mg/kg. | Drug: DS-1123<br>* starting intravenous (IV) dose of 0.1 mg/kg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) |  | Cycles 1, 2 : Days 1,2, 4, 8, 15 | 
| Number and severity of treatment emergent adverse events (TEAEs) |  | Day 1 to Day 31 | 
| Time of maximum concentration (Tmax) |  | Cycles 1, 2: Days 1,2, 4, 8, 15 | 
| Elimination rate constant (Kel) |  | Cycles 1, 2: Days 1,2, 4, 8, 15 | 
| area under the curve AUClast | pharmacokinetics profile | Cycles 1, 2: Days 1,2, 4, 8, 15 | 
| Area under the curve (AUCtau) |  | Cycles 1, 2: Days 1,2, 4, 8, 15 | 
| Area under the curve (AUCinf) |  | Cycles 1, 2: Days 1,2, 4, 8, 15 | 
| Half-life (T1/2) |  | Cycles 1, 2: Days 1,2, 4, 8, 15 | 
| Drug clearance (CL) |  | Cycles 1, 2: Days 1,2, 4, 8, 15 | 
| Volume of distribution (Vz) |  | Cycles 1, 2: Days 1,2, 4, 8, 15 | 
| Mean residence time (MRTinf) |  | Cycles 1, 2: Days 1,2, 4, 8, 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DS-1123a antibody | DS-1123a antibody on Cycle 1: Days 1,15; Cycles 2 and on: Day 1, Stop date, final follow-up date | Cycle 1: Days 1,15; Cycles 2: Day 1; Stop date, final follow-up date | 
| Change in Cytokines expression | Change in DS-1123a biomarkers Cytokines expression on Cycle 1: Days 1, 2, 15, 16; Cycle 2: Days 1, 2 | Cycle 1: Days 1, 2, 15, 16; Cycle 2: 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 tumors, phase 1, oncology, refractory, no standard treatment