Condition: Melanoma (Skin Cancer) · HER2-low Hormone Receptor Positive Breast Cancer · Sponsor: Aminex Therapeutics, Inc.
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.
This description comes directly from the study's public registry record.
Mark Burns, PhD · 425-524-1615 · mburns@aminextx.com
Always discuss trial participation with your own doctor first.
| University of Arizona | Tucson, Arizona, United States | Recruiting |
| START Los Angeles | Los Angeles, California, United States | Recruiting |
| Skin Cancer Institute | Englewood, Colorado, United States | Recruiting |
| Wayne State University - Barbara Ann Karmanos Cancer Institute | Detroit, Michigan, United States | Recruiting |
| Minnesota Oncology-Sarah Cannon Research Institute | Maple Grove, Minnesota, United States | Recruiting |
| START Cancer Research New York-Long Island | Lake Success, New York, United States | Recruiting |
| University of Cincinnati Medical Center | Cincinnati, Ohio, United States | Recruiting |
| Sarah Cannon Research Institute Oncology Partners | Nashville, Tennessee, United States | Recruiting |
| Vanderbilt-Ingram Cancer Institute | Nashville, Tennessee, United States | Recruiting |
| Texas Oncology | Austin, Texas, United States | Recruiting |
| Texas Oncology - Dallas SCRI | Dallas, Texas, United States | Recruiting |
| University of Texas-MD Anderson | Houston, Texas, United States | Recruiting |
+ 5 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07287917