Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat w momencie podpisania zgody na uczestnictwo
- •Rozumienie i podpisanie zgody na uczestnictwo w badaniu oraz gotowość do przestrzegania wszystkich procedur badania
- •Rozpoznanie nieoperacyjnego, zaawansowanego lokalnie lub przerzutowego guza litego (rak piersi ER+ HER2- lub czerniak)
- •Nowotwór potwierdzony badaniem histologicznym lub cytologicznym
- •Dla raka piersi: zaawansowany lub przerzutowy rak piersi z mutacją PIK3CA/AKT1/PTEN, po progresji na co najmniej 2 liniach terapii hormonalnej
- •Dla czerniaka: nieoperacyjny przerzutowy czerniak z progresją po poprzedniej immunoterapii
- •Mierzalne lub oceniane ogniska nowotworu zgodnie z kryteriami RECIST 1.1
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- May 12, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (12)
START Los Angeles
Los Angeles, United States
Skin Cancer Institute
Englewood, United States
Wayne State University - Barbara Ann Karmanos Cancer Institute
Detroit, United States
START Cancer Research New York-Long Island
Lake Success, United States
University of Cincinnati Medical Center
Cincinnati, United States
Vanderbilt-Ingram Cancer Institute
Nashville, United States
University of Texas-MD Anderson
Houston, United States
Lumi Research
Houston, United States
Laguna Clinical Research Associates
Laredo, United States
START Mountain Region
West Valley City, United States
Virginia Cancer Specialists-Fairfax
Fairfax, United States
University of Wisconsin-Madison Carbone Cancer Center
Madison, United States
Trial contact
Mark Burns, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.