drugset
drugset / Trial / NCT07287917

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

NCT07287917 ↗

Phase 1/2 Recruiting 92 enrolled Aminex Therapeutics, Inc.
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2026-01-26
Primary completion
2028-02-28
Completion
2028-12-29

Drugs

EvaluationDrugModalityDoseRoute
Subject AMXT 1501 Small molecule 300 mg Oral
Subject Eflornithine Small molecule 500 mg Oral
Background Capivasertib Small molecule 400 mg Oral
Background Fulvestrant Small molecule 500 mg Intramuscular
Background Pembrolizumab Monoclonal antibody 200 mg Intravenous

Indications

cutaneous melanoma hormone receptor-positive breast cancer