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A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer
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.
Study details:
This is a Phase 1b, open-label, multi-center study recruiting patients with R/R AML and MCL. The study will utilize an Accelerated Titration Design in the lower dose levels followed by a traditional 3+3 dose escalation design at higher dose levels until RP2D is determined. The starting dose will be 40 mg.
All potential study candidates will provide informed consent and will undergo screening procedures before participating in the study. After a screening period of up to 28 days, qualified patients will be enrolled to receive their assigned dose regimen of PEP07 monotherapy.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-07-17
Primary completion: 2025-12-31
Study completion finish: 2025-12-31
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05659732
Intervention or treatment
DRUG: PEP07
Conditions
- • Acute Myeloid Leukemia
- • Lymphoma, Mantle-Cell
Find a site
Closest Location:
Monash Medical Centre
Research sites nearby
Select from list below to view details:
Monash Medical Centre
Clayton, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: PEP07 Monotherapy (Arm A)
| DRUG: PEP07
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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 AML and MCL. | to find out the DLT | 4 weeks after first dosing |
To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of PEP07 monotherapy. | to find out the MTD | 4 weeks after first dosing |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
To assess the AUC from time zero to infinity (AUC0-inf) of single and multiple oral PEP07 as a monotherapy. | to know the PK profile | 6 months |
To assess the Time to maximum (peak) plasma concentration (Tmax) of single and multiple oral PEP07 as a monotherapy. | to know the PK profile | 6 months |
To assess the apparent half-life (t1/2) of single and multiple oral PEP07 as a monotherapy. | to know the PK profile | 6 months |
To assess the Maximum observed concentration (Cmax) of single and multiple oral PEP07 as a monotherapy. | to know the PK profile | 6 months |
To assess preliminary evidence of anti-tumor activity of PEP07 by progression free survival (PFS). | to know the efficacy | after first dosing to disease progression |
To assess preliminary evidence of anti-tumor activity of PEP07 by progression free survival (PFS). | to know the efficacy | after first dosing to disease progress |
Frequently Asked Questions
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