NCT06644755

First-in-Human Trial of DS-2243a in Participants With Advanced Solid Tumors

Phase 1, Open-Label, Multicenter, First-In-Human Trial of Ds-2243a in Participants With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This 2-part study will evaluate safety, tolerability, and clinical efficacy of DS-2243a as a treatment for participants with advanced solid tumors.

Detailed description

This is a global, multicenter, open-label, first-in-human, Phase 1 trial of DS-2243a as a treatment for locally advanced or metastatic synovial sarcoma (SS), myxoid/round cell liposarcoma (MRCLS), squamous cell carcinoma type non-small cell lung cancer (Sq-NSCLC), adenocarcinoma type non-small cell lung cancer (Ad-NSCLC), or urothelial carcinoma (UC) participants with HLA-A2 and/or NY-ESO positive. The trial consists of 2 parts: the Dose Escalation Part (Part 1) and the Dose Expansion Part (Part 2).

Conditions

• Solid Tumors
• Sarcoma

Interventions

Type	Name	Description
DRUG	DS-2243a	Escalation Part: DS-2243a will be administered at escalating doses to determine the RDE Expansion Part: DS-2243a will be administered at RDE

Timeline

• Start date: 2024-11-14
• Primary completion: 2028-11-30
• Completion: 2028-11-30
• First posted: 2024-10-16
• Last updated: 2025-07-24

Locations

7 sites across 5 countries: United States, Belgium, France, Netherlands, South Korea

Regulatory

• FDA-regulated drug study