RecruitingPhase 1NCT06644755

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


Sponsor

Daiichi Sankyo

Enrollment

150 participants

Start Date

Nov 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing DS-2243a, a new experimental treatment, in patients with certain advanced solid tumors that have not responded to standard therapies. The drug targets cancer cells that carry a specific protein identified through a genetic marker. **You may be eligible if...** - You are 18 years or older - You have advanced (metastatic or unresectable) synovial sarcoma, myxoid/round cell liposarcoma, non-small cell lung cancer, or urothelial (bladder/urinary tract) cancer - Your cancer has not responded to or is no longer benefiting from standard treatment - You carry the HLA-A*02 genetic marker (a common immune system marker detectable by a blood test) - You have measurable disease on a scan - You are in good physical health (ECOG score 0 or 1) **You may NOT be eligible if...** - You do not carry the required HLA-A*02 genetic marker - You have poor organ function (low blood counts, kidney or liver problems) - You are unable to provide a tumor tissue sample - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDS-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, United States

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

UZ Leuven Europe Leuven

Leuven, Belgium

Centre Leon Berard

Lyon, France

Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)

Amsterdam, Netherlands

Seoul National University Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06644755


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