OncoMatch/Clinical Trials/NCT05983523
A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients with Advanced or Metastatic Solid Tumors
Is NCT05983523 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies PEP07 for advanced solid tumor.
Treatment: PEP07 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard treatment
who have failed on or are intolerant to standard treatment or have no access to standard treatment
Cannot have received: anti-cancer therapy
Exception: within 14 days or 5 half-lives (whichever is shorter) or immunotherapy within 30 days prior to the first dose
Subjects 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 study treatment.
Lab requirements
Blood counts
ANC ≥ 1500/mm3; Platelet counts ≥ 100,000/mm3; Hemoglobin ≥ 9 g/dL
Kidney function
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 (≤ 5 × ULN, if attributable to liver metastases); ALT ≤ 2.5 × ULN (≤ 5 × ULN, if attributable to liver metastases); Bilirubin ≤ 1.5 × ULN
Cardiac function
QTcF interval ≤ 450 msec at screening (mean of triplicate readings within approximately 5 minutes); NYHA < Class III; left ventricular ejection fraction ≥ 45% at baseline; no history of cardiac ischemia within past 6 months; no prior history of cardiac arrhythmia requiring treatment
adequate renal function as demonstrated by a calculated creatinine clearance ≥ 50 mL/min; adequate liver function as demonstrated by: AST ≤ 2.5 × ULN (≤ 5 × ULN, if attributable to liver metastases), ALT ≤ 2.5 × ULN (≤ 5 × ULN, if attributable to liver metastases), Bilirubin ≤ 1.5 × ULN; adequate bone marrow function as demonstrated by: ANC ≥ 1500/mm3, Platelet counts ≥ 100,000/mm3, Hemoglobin ≥ 9 g/dL; QTcF interval > 450 msec at screening (within 28 days prior to the first dose of study treatment, mean of triplicate readings within approximately 5 minutes); cardiovascular disability status of NYHA ≥ Class III, left ventricular ejection fraction < 45% at baseline, history of cardiac ischemia within the past 6 months, or prior history of cardiac arrhythmia requiring treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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