Clinical Trial

A Study to Investigate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy With GenSci122 in Participants With Advanced Solid Tumors

Recruiting Phase 1
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Summary
This is a first-in-human (FIH), multicenter, open-label, phase I study to evaluate the safety, tolerability, PK and preliminary efficacy of GenSci122 in participants with advanced solid tumors. The study consists of 2 parts: Part 1- dose-escalation and Part 2- dose expansion. The primary endpoint of Dose escalation is To assess the safety and tolerability of GenSci122. The primary endpoint of Dose expansion is to evaluate the preliminary anti-tumor activity of GenSci122 in participants with advanced solid tumors.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-08.
Status change: Not Yet Recruiting → Recruiting 2025-01-20
Trial Details
NCT Number NCT06772415
Lead Sponsor Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions Advanced Solid Tumor
Enrollment 163 participants
Start Date 2025-01-08
Primary Completion 2028-12 (estimated)
Study Completion 2031-03 (estimated)
Updated on ClinicalTrials.gov 2025-01-22