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RECRUITING Phase 1

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

NCT07287917 · View on ClinicalTrials.gov ↗

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.

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

1 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aminex Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07287917 reports 8 study locations spanning 6 distinct geographic areas — top geographies include Texas, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07287917?

This trial is sponsored by Aminex Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial