drugset / Trial / NCT07230977

GenSci139 in Patients With Advanced Solid Tumors

NCT07230977 ↗

Phase 1 Recruiting 280 enrolled Changchun GeneScience Pharmaceutical Co., Ltd.
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2025-11-19
Primary completion
2028-07-07
Completion
2029-01-08

Drugs

EvaluationDrugModalityDoseRoute
Subject GenSci139 Other / unclassified — —

Indications