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

Daiichi Sankyo

Summary

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

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).

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Key Inclusion Criteria: 1. Sign and date the main ICF. 2. Adults ≥18 years at the time the biosample ICF or main ICF, whichever is signed first. Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old. 3. One of the following histologically or cytologically documented cancers: Advanced (metastatic or unresectable) SS Advanced (metastatic or unresectable) MRCLS Metastatic or unresectable locally advanced NSCLC (Ad/Sq) Metastatic or unresectable locally advanced UC 4. Relapsed from, refractory to, or intolerant to appropriate therapies…

Interventions

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

Locations (7)

Dana-Farber Cancer Institute
Boston, Massachusetts
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York
Sarah Cannon Research Institute
Nashville, Tennessee
UZ Leuven Europe Leuven
Leuven
Centre Leon Berard
Lyon
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)
Amsterdam