A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients with Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age20+
SponsorPharmaEngine
About this trial
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
Qualifiers
Aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN, if attributable to liver metastases)
Alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN, if attributable to liver metastases)
Bilirubin ≤ 1.5 × ULN
Absolute neutrophil count (ANC) ≥ 1500/mm3
Disqualifiers
Pregnant or breastfeeding females.
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.
Subjects have received strong or moderated cytochrome P450 3A4 (CYP3A4) inhibitors or CYP inducers such as ketoconazole, erythromycin, netupitant, isavuconazole etc. within 5 half-lives or 7 days (whichever is the shortest) prior to the first dose of study treatment.
Known history of or positive screening result for human immunodeficiency virus (HIV) antibody.
Trial design
Treatments tested in this trial
- PEP07
Treatment groups
54 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov