Clinical Trial

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

Recruiting Phase 1/2
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Summary
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 also evaluate pharmacokinetics, pharmacodynamics, disease control, and overall safety.
Protocol Amendment History 2 changes
notable Trial sites expanded: 12 -> 17 locations 2026-07-16
notable Trial sites expanded: 8 -> 12 locations 2026-05-06
Trial Details
NCT Number NCT07287917
Lead Sponsor Aminex Therapeutics, Inc.
Conditions Melanoma (Skin Cancer), HER2-low Hormone Receptor Positive Breast Cancer
Enrollment 92 participants
Start Date 2026-01-26
Primary Completion 2028-02-28 (estimated)
Study Completion 2028-12-29 (estimated)
Updated on ClinicalTrials.gov 2026-07-15