drugset / Trial / NCT06772415

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

NCT06772415 ↗

Phase 1 Recruiting 163 enrolled Changchun GeneScience Pharmaceutical Co., Ltd.
NaSequentialOpen-labelTreatment

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.

Timeline

Start
2025-01-08
Primary completion
2028-12
Completion
2031-03

Drugs

EvaluationDrugModalityDoseRoute
Subject GenSci122 Unknown 50 mg Oral
Subject GenSci122 Unknown 250 mg Oral

Indications