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

ClinicalTrials.gov ID: NCT07287917

Public ClinicalTrials.gov record NCT07287917. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 3, 2026, 12:00 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07287917
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Aminex Therapeutics, Inc.; Industry
Enrollment: 92 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 25, 2026
Primary completion: Feb 27, 2028
Completion: Dec 28, 2028
Last update posted: Jul 14, 2026

2026 – 2028

United States locations

U.S. sites: 17
U.S. states: 12
U.S. cities: 15

Facility	City	State	ZIP	Site status
University of Arizona	Tucson	Arizona	85724	Recruiting
START Los Angeles	Los Angeles	California	90025	Recruiting
Skin Cancer Institute	Englewood	Colorado	80113	Recruiting
Wayne State University - Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	48201	Recruiting
Minnesota Oncology-Sarah Cannon Research Institute	Maple Grove	Minnesota	55369	Recruiting
START Cancer Research New York-Long Island	Lake Success	New York	11042	Recruiting
University of Cincinnati Medical Center	Cincinnati	Ohio	45219	Recruiting
Sarah Cannon Research Institute Oncology Partners	Nashville	Tennessee	37203	Recruiting
Vanderbilt-Ingram Cancer Institute	Nashville	Tennessee	37232	Recruiting
Texas Oncology	Austin	Texas	78731	Recruiting
Texas Oncology - Dallas SCRI	Dallas	Texas	75246	Recruiting
University of Texas-MD Anderson	Houston	Texas	77030	Recruiting
Lumi Research	Houston	Texas	77090	Recruiting
Laguna Clinical Research Associates	Laredo	Texas	78041	Recruiting
START Mountain Region	West Valley City	Utah	84119	Recruiting
Virginia Cancer Specialists-Fairfax	Fairfax	Virginia	22031	Recruiting
University of Wisconsin-Madison Carbone Cancer Center	Madison	Wisconsin	53706	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07287917, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 14, 2026 · Synced Sep 3, 2026

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The complete protocol, eligibility criteria, and contact information for NCT07287917 live on ClinicalTrials.gov.

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