drugset / Trial / NCT06772415
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy With GenSci122 in Participants With Advanced Solid Tumors
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GenSci122 | Unknown | 50 mg | Oral |
| Subject | GenSci122 | Unknown | 250 mg | Oral |