A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients with Advanced or Metastatic Solid Tumors
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1\. Subjects must be ≥ 20 years of age 2a. For subject in the dose escalation stage: Subjects with advanced or metastatic solid tumors who have failed on or are intolerant to standard treatment or have no access to standard treatment. 2b. For subject in the dose expansion stage: Subjects with histologically or cytologically confirmed malignant solid tumors which are advanced or metastatic, who have failed on or are intolerant to standard treatment or have no access to standard treatment. 3\. At least one measurable lesion according to the RECIST version 1.1. 4\. Subjects must have ECOG Performance score of 0-1. 5\. Subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 50 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula. 6\. Subject must have adequate liver function as demonstrated by: * Aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN, if attributable to liver