Clinical Trial

A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer

Recruiting Phase 1
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Summary
The goal of this clinical trial is * To assess the safety and tolerability of PEP07 administered orally as a single dose and at escalating dose levels, and, to determine the dose-limiting toxicity (DLT) of study treatment in patients with Acute Myeloid Leukemia (AML) and Mantle Cell Lymphoma (MCL). * 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, HSCT or other anti-cancer treatment is required, or the Sponsor ends the study, whichever occurs first.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-12-19; most recent amendment 2025-07-28.
Status change: Not Yet Recruiting → Recruiting 2023-07-17
Trial Details
NCT Number NCT05659732
Lead Sponsor PharmaEngine
Conditions Acute Myeloid Leukemia, Lymphoma, Mantle-Cell
Enrollment 32 participants
Start Date 2023-07-17
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-31