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First-in-human Phase 1 trial of DS5361b ± pembrolizumab in advanced solid tumors
jRCT2031250489Phase 1Recruiting
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Start
- Feb 2026
- Modality
- Small Molecules
- Countries
- 2
01
Overview
Phase 1, open-label trial of DS5361b in Nonhematologic neoplasms, non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC) (3 arms), sponsored by Daiichi Sankyo Co., Ltd. Primary endpoints: Dose-limiting toxicities (DLTs) in Parts 1 and 2, Treatment-emergent adverse events (TEAEs) in Parts 1, 2, and 3 and 1 more. Started Feb 2026; status: recruiting.
02
Drugs
DS5361b
03
Conditions
Nonhematologic neoplasmsnon-small cell lung cancer (NSCLC)head and neck squamous cell carcinoma (HNSCC)
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