Clinical Trial

GenSci139 in Patients With Advanced Solid Tumors

Recruiting Phase 1
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Summary
This is a phase I, two-part, multicenter, first-in-human study. The Part 1 study will assess the safety, tolerability, preliminary anti-tumor activities, PK profile, immunogenicity and biomarker of GenSci139 in participants with locally advanced or metastatic solid tumors, as well as identity MTD (if any) and RDE. The Part 2 study is to further evaluate the preliminary anti-tumor activities, safety, PK profile, immunogenicity and biomarker of GenSci139 at RDE dose levels with selected advanced cancers.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-13.
Status change: Not Yet Recruiting → Recruiting 2025-12-18
Trial Details
NCT Number NCT07230977
Lead Sponsor Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions Advanced Solid Tumors
Enrollment 280 participants
Start Date 2025-11-19
Primary Completion 2028-07-07 (estimated)
Study Completion 2029-01-08 (estimated)
Updated on ClinicalTrials.gov 2025-12-24