clinical trial · NCT06772415
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy With GenSci122 in Participants With Advanced Solid Tumors
Changchun GeneScience Pharmaceutical Co., Ltd.·phase1·recruiting·n = 163
Advanced Solid TumorGenSci122 tablet 50mgGenSci122 tablet 250mg
brief 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.
started
Jan 8, 2025
primary completion
Dec 1, 2028
completion
Mar 1, 2031
last updated
Jan 22, 2025
official title
A Phase I Study of Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral KIF18A Inhibitor GenSci122 in Participants With Advanced Solid Tumors
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol