Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors (NCT07287917)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Arizona — Tucson, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (17 Sites)
- University of Arizona — Tucson, Arizona
- START Los Angeles — Los Angeles, California
- Skin Cancer Institute — Englewood, Colorado
- Wayne State University - Barbara Ann Karmanos Cancer Institute — Detroit, Michigan
- Minnesota Oncology-Sarah Cannon Research Institute — Maple Grove, Minnesota
- START Cancer Research New York-Long Island — Lake Success, New York
- University of Cincinnati Medical Center — Cincinnati, Ohio
- Sarah Cannon Research Institute Oncology Partners — Nashville, Tennessee
- Vanderbilt-Ingram Cancer Institute — Nashville, Tennessee
- Texas Oncology — Austin, Texas
- Texas Oncology - Dallas SCRI — Dallas, Texas
- University of Texas-MD Anderson — Houston, Texas
- Lumi Research — Houston, Texas
- Laguna Clinical Research Associates — Laredo, Texas
- START Mountain Region — West Valley City, Utah
- Virginia Cancer Specialists-Fairfax — Fairfax, Virginia
- University of Wisconsin-Madison Carbone Cancer Center — Madison, Wisconsin
📞 Contact the Study Coordinator
Phone: (425) 524-1615
Email: mburns@aminextx.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.