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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Eligibility criteria expanded, about 423 words
    • Secondary endpoints: details revised at 3 of 8 entries
  2. Recruitment opened
    • Start date changed from estimate of Mar 14, 2026 to Apr 1, 2026
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07407504
Lead Sponsor Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions
(from sponsor)		 Locally Advanced or Metastatic Solid Tumors With PIK3CA-mutated
Enrollment 186 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov