OncoMatch/Clinical Trials/NCT05659732
A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer
Is NCT05659732 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies PEP07 for acute myeloid leukemia.
Treatment: PEP07 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemoimmunotherapy
have received at least two prior lines of treatment, including chemoimmunotherapy and BTKi
Must have received: BTK inhibitor
have received at least two prior lines of treatment, including chemoimmunotherapy and BTKi
Cannot have received: anti-cancer therapy
Exception: hydroxyurea or dexamethasone at any time prior to the start of study treatment is an exception
Patients who have received anti-cancer therapy including chemotherapy, radiotherapy, hormonal, or any investigational therapy within 14 days or 5 half-lives (whichever is shorter), or immunotherapy within 30 days prior to the first dose of PEP07. Patients who have received hydroxyurea or dexamethasone at any time prior to the start of study treatment is an exception to this criterion.
Cannot have received: allogeneic hematopoietic stem cell transplant
Patients who have undergone allogeneic hematopoietic stem cell transplant (HSCT) within 60 days of PEP07 treatment
Lab requirements
Kidney function
calculated creatinine clearance ≥ 50 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula
Liver function
AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN; bilirubin ≤ 1.5 × ULN (unless considered due to leukemic organ involvement or Gilbert's Syndrome per PI/sponsor discussion)
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50% measured by MUGA or echocardiogram
adequate renal function as demonstrated by a calculated creatinine clearance ≥ 50 mL/min; adequate liver function as demonstrated by: AST ≤ 2.5 × ULN, ALT ≤ 2.5 × ULN, bilirubin ≤ 1.5 × ULN (unless considered due to leukemic organ involvement or Gilbert's Syndrome per PI/sponsor discussion); Left ventricular ejection fraction (LVEF) ≥ 50% measured by MUGA or echocardiogram
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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