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NCT07287917 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Melanoma (Skin Cancer) and HER2-low Hormone Receptor Positive Breast Cancer, sponsored by Aminex Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
92
Enrollment target
8
Study locations

NCT07287917 is a Phase 1 study of Melanoma (Skin Cancer) and HER2-low Hormone Receptor Positive Breast Cancer that is actively recruiting participants, run by Aminex Therapeutics. The registered enrollment target is 92 participants, below the 331-participant average among 5 other Melanoma (Skin Cancer) trials with a reported enrollment target (72% lower). The trial reports 8 study locations across 6 states.

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The verdict

NCT07287917, a Phase 1 study of Melanoma (Skin Cancer) and HER2-low Hormone Receptor Positive Breast Cancer, is actively recruiting participants, sponsored by Aminex Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
92 participants
Enrollment target
8
Study locations

Study 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.

Conditions Studied

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

Interventions

  • DRUG Pembrolizumab
  • DRUG DFMO
  • DRUG Fulvestrant
  • DRUG Capivasertib
  • DRUG AMXT 1501 Dicaprate

Study Locations (8)

Texas

  • University of Texas-MD Anderson - Houston
  • Lumi Research - Houston
  • Laguna Clinical Research Associates - Laredo

California

  • START Los Angeles - Los Angeles

New York

  • START Cancer Research New York-Long Island - Lake Success

Utah

  • START Mountain Region - West Valley City

Virginia

  • Virginia Cancer Specialists-Fairfax - Fairfax

Wisconsin

  • University of Wisconsin-Madison Carbone Cancer Center - Madison

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2026-01-26
Est. Completion 2028-12-29
Phase Phase 1

Sponsor

Aminex Therapeutics

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07287917

The ClinicalTrials.gov registry entry for NCT07287917 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 331-participant average among 5 other Melanoma (Skin Cancer) trials with a reported enrollment target (72% lower). The listed sponsor is Aminex Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Melanoma (Skin Cancer) appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT07287917 reports 8 study locations spanning 6 distinct geographic areas - top geographies include Texas, California, New York.

Frequently Asked Questions

What is clinical trial NCT07287917 about?

NCT07287917 is a clinical study titled "Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors". 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...

What is the current status of trial NCT07287917?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 92 participants. The study started on 2026-01-26. Estimated completion is 2028-12-29.

What conditions does trial NCT07287917 study?

This clinical trial studies the following conditions: Melanoma (Skin Cancer), HER2-low Hormone Receptor Positive Breast Cancer.

What interventions are being tested in trial NCT07287917?

The interventions under investigation include: Pembrolizumab (DRUG), DFMO (DRUG), Fulvestrant (DRUG), Capivasertib (DRUG), AMXT 1501 Dicaprate (DRUG).

Who is sponsoring clinical trial NCT07287917?

This trial is sponsored by Aminex Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07287917 being conducted?

This trial has 8 study locations across California, New York, Texas, Utah, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.