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

Aminex Therapeutics, Inc. · 2026
ClinicalTrials.gov · Datasets · License: Public Domain · 2026
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advanced-solid-tumorbreast-cancercombination-therapymelanomamelanoma-skin-cancer
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.
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