drugset / Trial / NCT05983523

A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients with Advanced or Metastatic Solid Tumors

NCT05983523 ↗

Phase 1 Recruiting 54 enrolled PharmaEngine
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

EvaluationDrugModalityDoseRoute
Subject PEP07 Small molecule 20 mg Oral
Subject PEP07 Small molecule 150 mg Oral