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Recruiting Phase 1, Phase 2 NCT05875168

First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors

Trial Parameters

Condition Advanced Solid Tumor
Sponsor Daiichi Sankyo
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 540
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-08-18
Completion 2026-03-17
Interventions
DS-3939a

Brief Summary

This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.

Eligibility Criteria

Inclusion Criteria: * Sign and date the main Informed Consent Form (ICF). * Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition within 28 days of enrollment. * Has adequate organ function. * Measurable disease based on RECIST V1.1. * Eastern Cooperative Oncology Group performance status score of 0 or 1. Additional inclusion criteria for Part 1 * Has a histologically or cytologically documented locally advanced, metastatic, or unresectable solid malignant tumors. Additional inclusion criteria for Part 2 * Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria and documented radiographic disease progression during or after the most recent anticancer therapy. * Is able to provide either of the following baseline tumor samples: * Fresh tumor biopsy samples meeting either of the following requirements that were obtained during the Main Screening or Tissue Screening Pe

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