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

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).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Melanoma (Skin Cancer)
• HER2-low Hormone Receptor Positive Breast Cancer

Eligibility basics and study details

Study type

Interventional

Phase

Phase 1/2

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

Aminex Therapeutics, Inc.

Last updated on ClinicalTrials.gov

September 4, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites