Clinical Trial

GenSci145 as Monotherapy or in Combination Therapy, in Participants With PIK3CA-mutated, Locally Advanced or Metastatic Solid Tumors.

Recruiting Phase 1
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Summary
An international, multicenter, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of GenSci145, as monotherapy or in combination therapy, in participants with PIK3CA-mutated, locally advanced or metastatic solid tumors.
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-28
Trial Details
NCT Number NCT07407504
Lead Sponsor Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions Locally Advanced or Metastatic Solid Tumors With PIK3CA-mutated
Enrollment 186 participants
Start Date 2026-04-01
Primary Completion 2028-11-08 (estimated)
Study Completion 2029-02-21 (estimated)
Updated on ClinicalTrials.gov 2026-05-27