Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors

This study will evaluate the safety, tolerability, and preliminary effectiveness of AMXT 1501 and DFMO when combined with standard treatments for advanced solid tumors. The trial includes two groups: * Cohort 1: Patients with ER+ / HER2- breast cancer receiving fulvestrant and capivasertib * Cohort 2: Patients with unresectable or metastatic cutaneous melanoma receiving pembrolizumab The Phase 1b portion will find the recommended Phase 2 dose (RP2D). The Phase 2 portion will further evaluate clinical activity at the RP2D using response criteria for solid tumors (RECIST 1.1). The study will

Trial Details

NCT ID
NCT07287917
Phase
PHASE1 / PHASE2
Sponsor
Aminex Therapeutics, Inc.
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • AMXT 1501 Dicaprate
  • DFMO
  • Fulvestrant
  • Capivasertib
  • Pembrolizumab
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Los Angeles, California, United States|34.05223,-118.24368
  • Englewood, Colorado, United States|39.64777,-104.98776
  • Detroit, Michigan, United States|42.33143,-83.04575
  • Maple Grove, Minnesota, United States|45.07246,-93.45579

Key Eligibility Criteria

  • Patients will be eligible for study participation only if they meet ALL the inclusion criteria applicable to their diagnosis.
  • Understand and sign the informed consent form (ICF) and be willing to comply with all study procedures before any study specific procedures are con…
  • ≥18 years old at the time of signing the informed consent.
  • Diagnosed with unresectable, locally advanced, or metastatic solid tumors including ER+ HER2- breast cancer (Cohort 1) or melanoma (Cohort 2)

For full eligibility, visit ClinicalTrials.gov.

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