RecruitingPhase 1Phase 2NCT07287917

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

A Phase 1b/2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies

Sponsor

Aminex Therapeutics, Inc.

Enrollment

92 participants

Start Date

Jan 26, 2026

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing two drugs — AMXT 1501 and DFMO — combined with standard cancer therapies in people with advanced breast cancer (Cohort 1) or melanoma (Cohort 2). **You may be eligible if...** - You are 18 or older with confirmed advanced or metastatic cancer - For breast cancer: your cancer is HR+/HER2-negative with specific gene changes (PIK3CA/AKT1/PTEN), and you have progressed on at least 2 hormone-based regimens - For melanoma: your melanoma has progressed after standard immunotherapy (anti-PD-1) - Your disease is confirmed by tissue or cell testing - Your organ function is adequate **You may NOT be eligible if...** - You have a different cancer type not included in the study cohorts - You have not yet tried the required prior treatments - You have serious cardiac, liver, or kidney problems - You have active brain metastases that have not been treated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAMXT 1501 Dicaprate

Formulation: Enteric-coated oral tablet (100 mg base) Dose: Body-surface-area-adjusted; starting dose = 300 mg PO BID; may escalate per 3 + 3 design Administration: By mouth on an empty stomach (AM and PM doses)

DRUGDFMO

Formulation: 500 mg gel capsule Dose: 500 mg PO once or twice daily, per cohort dose level

DRUGFulvestrant

Dose: 500 mg IM injection on Day 2 and Day 15 of Cycle 1, then Day 2 of each subsequent 28-day cycle

DRUGCapivasertib

Dose: 400 mg PO BID for 4 days on / 3 days off each week (28-day cycle)

DRUGPembrolizumab

200 mg IV infusion every 3 weeks (Q3W) for up to 12 months

Locations(8)

START Los Angeles

Los Angeles, California, United States

START Cancer Research New York-Long Island

Lake Success, New York, United States

University of Texas-MD Anderson

Houston, Texas, United States

Lumi Research

Houston, Texas, United States

Laguna Clinical Research Associates

Laredo, Texas, United States

START Mountain Region

West Valley City, Utah, United States

Virginia Cancer Specialists-Fairfax

Fairfax, Virginia, United States

University of Wisconsin-Madison Carbone Cancer Center

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT07287917

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