drugset / Trial / NCT05983523
A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients with Advanced or Metastatic Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
The goal of this clinical trial is To establish the safety profile and determine the dose-limited toxicity (DLT) of PEP07 monotherapy in patients with advanced or metastatic solid tumors. To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of PEP07 monotherapy. Participants will receive PEP07 administered orally once daily (QD) for 2 consecutive days and 5 days off, every week for 4 weeks until disease progression, intolerable toxicity, confirmed pregnancy, death, consent withdrawal, or other anti-cancer treatment is required, or the Sponsor ends the study, whichever occurs first.
Timeline
- Start
- 2024-03-27
- Primary completion
- 2027-02-25
- Completion
- 2027-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEP07 | Small molecule | 20 mg | Oral |
| Subject | PEP07 | Small molecule | 150 mg | Oral |