drugset / Trial / NCT05751356
TR128 in Patients With Advanced Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
This is a open-label, 3+3 design, dose escalation and expansion, phase I study, to evaluate the safety and tolerability, and to determine the Recommended Phase II Dose (RP2D) of TR128 when administered qd in patients with advanced solid tumors. Up to 5 cohorts of 3-6 patients each will be treated in dose escalation phase of the study. One cycle is 28 days. Dose expansion phase to further evaluate the safety, tolerability and preliminary anti-tumor activity of TR128 at the RP2D.
Timeline
- Start
- 2024-02-23
- Primary completion
- 2025-08-30
- Completion
- 2025-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TR128 | Unknown | 100 mg | Oral |
| Subject | TR128 | Unknown | 500 mg | Oral |