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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: Recruiting Phase 1 study of Melanoma (Skin Cancer) and HER2-low Hormone Receptor Positive Breast Cancer, sponsored by Aminex Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants experiencing dose-limiting toxicities as defined in the protocol, including hematologic and non-hematologic toxicities, treatment-related dosing delays, missed doses, or any toxicity leading to discontinuation during the DLT evaluation period.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2026-01-26 |
| Est. Completion | 2028-12-29 |
| Phase | Phase 1 |
What NCT07287917 shows while recruiting
NCT07287917 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 331-participant average among 5 other Melanoma (Skin Cancer) trials with a reported enrollment target (72% lower).
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 lists 8 locations in 6 states (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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