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Recruiting Phase 1 NCT07159126

A Study of DS3610a in Participants With Advanced Solid Tumor

Trial Parameters

Condition Solid Tumors
Sponsor Daiichi Sankyo
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 70
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-10-09
Completion 2028-09-01
Interventions
DS3610a

Brief Summary

This study is designed to assess the safety, tolerability, and efficacy of DS3610a, given as a single agent to participants with advanced or metastatic solid tumors.

Eligibility Criteria

Key Inclusion Criteria: * Sign and date the main ICF, prior to the start of any trial-specific procedures. * Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old). * Relapsed from, refractory to, or intolerant to appropriate therapies (eg, SoC) to provide clinical benefit for their condition as assessed by their physician and/or investigator. * Is willing and able to provide an adequate pretreatment tissue sample prior to trial intervention or archival tumor tissue sample. * Has measurable disease based on local CT/MRI imaging as assessed by the investigator per RECIST v1.1; radiographic tumor assessment must be performed within 28 days prior to initiation of trial intervention. Key Exclusion Criteria: \*Inadequate washout period before initiation of trial intervention, defined as: Major surgery: ≤4 weeks (or ≤2 weeks for low-invasive cases) Curative radiation therapy: ≤4

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