A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of GenSci140 in Participants With Advanced Solid Tumors

This is a phase I, multi-center, open-label, dose-escalation (Part 1) and dose-expansion (Part 2) first-in-human study in China to evaluate the safety, tolerability, PK profile and efficacy of GenSci140 in participants with advanced solid tumors, and to determine the MTD (if any) and RDE. The dose-expansion study aims to evaluate the efficacy, safety and PK profile of GenSci140 in the treatment of ovarian cancer or other FRα-positive advanced solid tumors at different dose levels, and to select an appropriate RP2D (if applicable).

NCT Number	NCT07251166
Lead Sponsor	Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions	Advanced Solid Tumors
Enrollment	170 participants
Start Date	2025-12-10
Primary Completion	2028-03 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2025-12-24