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

Trial Details

NCT ID
NCT05659732
Phase
PHASE1
Sponsor
PharmaEngine
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • PEP07
Locations (sample)
  • Clayton, Victoria, Australia|-37.91667,145.11667
  • Kaohsiung City, Taiwan|22.61626,120.31333
  • Taichung, Taiwan|24.1469,120.6839
  • Taipei, Taiwan|25.05306,121.52639
  • Taipei, Taiwan|25.05306,121.52639

Key Eligibility Criteria

  • Must be ≥ 18 years of age.
  • Must have histological or cytological confirmation advanced hematologic malignancy including:
  • Relapsed or refractory AML (by the 5th edition of World Health Organization \[WHO\] classification of Hematolymphoid tumors)
  • OR Relapsed or refractory MCL and have received at least two prior lines of treatment, including chemoimmunotherapy and BTKi and at least 1 measura…

For full eligibility, visit ClinicalTrials.gov.

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