RecruitingPhase 1NCT05659732

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

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

Sponsor

PharmaEngine

Enrollment

32 participants

Start Date

Jul 17, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Lymphoma, Mantle-Cell

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing a new experimental drug called PEP07, which targets a protein involved in cancer cell growth (Checkpoint Kinase 1), in people with advanced blood cancers such as acute myeloid leukemia (AML) or mantle cell lymphoma (MCL) that have come back or stopped responding to prior treatment. **You may be eligible if...** - You are 18 or older - You have relapsed or treatment-resistant AML, or relapsed/refractory mantle cell lymphoma (MCL) after at least two prior treatments - You are in reasonably good health (ECOG score 0–2) - Your kidney, liver, and heart function are within acceptable ranges - If female, you have a negative pregnancy test before starting treatment **You may NOT be eligible if...** - You have not been diagnosed with AML or MCL - Your organ function does not meet the study's requirements - You have significant side effects from prior treatments that have not resolved - You are pregnant or breastfeeding - You are unable to use effective contraception if you could become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPEP07

PEP07 is a selective Chk1 inhibitor maleate drug which is supplied as a hard gelatin capsule. PEP07 will be provided as 20 mg and 150 mg strength capsules to be administrated orally. Patients allocated to different dose levels of PEP07 monotherapy will receive either 20 mg or 150 mg oral capsules for 2 consecutive days followed by 5 days treatment off (2-on/5-off) schedule every week, 4 weeks as a treatment cycle.

Locations(5)

Monash Medical Centre

Clayton, Victoria, Australia

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Chang Gung Memorial Hospital- Linkou

Taipei, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT05659732

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