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DS-3939a in Advanced Solid Tumors
NCT05875168Phase 2
Key facts
- Status
- Recruiting
- Start
- Aug 2023
- Primary completion
- Aug 2028
- Countries
- 8
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Modality
- Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Small Molecules
- Drugs
- DS-3939
- Conditions
- solid tumor
01
Overview
Phase 2, open-label trial of DS-3939 in solid tumor (2 arms), sponsored by Daiichi Sankyo Co., Ltd. Primary endpoints: Dose-limiting Toxicities at 3 months, Treatment-emergent Adverse Events and Serious Adverse Events at 31 months and 2 more. Started Aug 2023; status: recruiting.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Dose Escalation (Part 1)
Participants with locally advanced, metastatic, or unresectable tumors who will receive an intravenous (IV) infusion of DS-3939a starting at 1 mg/kg.
Dose Expansion (Part 2)
Multiple expansion cohorts targeting various advanced solid tumors.
03
Who it enrols
Patients with locally advanced, metastatic, or unresectable solid malignant tumors, adequate organ function, LVEF >= 50%, and ECOG 0-1. Excludes patients with prior MUC1/TA-MUC1 targeted therapy, active CNS metastases, ILD/pneumonitis, active HIV/HBV/HCV, or recent cardiovascular events.
04
Endpoints
Primary
Dose-limiting Toxicities
Treatment-emergent Adverse Events and Serious Adverse Events
Objective Response Rate
PSA50 Response Rate
Secondary
Objective Response Rate
Disease Control Rate
Duration of Response
Time to Response
Progression Free Survival
Overall Survival
TA-MUC1 Expression by Immunohistochemistry
Area Under the Plasma Concentration Curve
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