Actively Recruiting
Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors
Led by Aminex Therapeutics, Inc. · Updated on 2026-05-12
92
Participants Needed
12
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and sign informed consent and comply with study procedures
- 18 years or older at consent
- Diagnosed with unresectable, locally advanced, or metastatic ER+ HER2- breast cancer or melanoma
- Breast cancer patients must have progressed on at least 2 endocrine therapies in metastatic setting or recurred within 12 months of adjuvant therapy
- Melanoma patients must have progressed on prior immune checkpoint inhibitors and BRAF or MEK inhibitors if BRAF mutant
- Have measurable or evaluable disease by RECIST 1.1
- Stable treated brain metastases allowed if no progression for at least 4 weeks and no steroid use for 14 days prior
- Willing to undergo tumor biopsy if safe; archival sample allowed within 1 year
- ECOG performance status 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ function as defined in protocol
- Fully recovered from prior anti-cancer therapy toxicities with specified minimum intervals
- No active secondary malignancies except specified treated cancers in remission
- Willingness and ability to comply with study procedures and follow-up
- Use of highly effective contraception during study and for 3 months after
- Able to take oral medications
You will not qualify if you...
- Melanoma patients with recent radiation or biological therapy within 4 weeks or unresolved related adverse events
- Need for other systemic or localized cancer therapies during study
- Chronic systemic steroid or immunosuppressive therapy within 2 weeks before treatment
- Intolerance to any study drugs or standard therapies
- Significant central nervous system diseases or active CNS metastases not stable
- Active inflammatory neurological disorders
- Recent chemotherapy, radiation, surgery, or targeted therapy within specified timeframes
- Prior use of Adriamycin not allowed
- Active autoimmune diseases requiring systemic treatment in past 2 years
- Significant uncontrolled cardiovascular diseases or ECG abnormalities
- Major surgery within 4 weeks prior to treatment
- Active infections requiring treatment
- Pregnant or lactating women; women of childbearing potential must have negative pregnancy test
- Unresolved toxicities from prior therapies above Grade 1 except stable chronic toxicities
- Inability or unwillingness to comply with study procedures
- Active liver disease or serious nonmalignant disease compromising study objectives
- Current or recent participation in another investigational agent study except specified
- Gastrointestinal conditions affecting drug absorption
- Allergic reactions to study drugs or related compounds
- Use of other hormonal therapies in breast cancer cohort except LHRH agonist
- Use of biotin supplements above daily adequate intake
- Uncontrolled or life-threatening infections
- History of stem cell or solid organ transplant
- Additional pembrolizumab-specific exclusions including severe hypersensitivity, recent lung radiation, pneumonitis, and transplant history
AI-Screening
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Trial Site Locations
Total: 12 locations
1
START Los Angeles
Los Angeles, California, United States, 90025
Actively Recruiting
2
Skin Cancer Institute
Englewood, Colorado, United States, 80113
Actively Recruiting
3
Wayne State University - Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
4
START Cancer Research New York-Long Island
Lake Success, New York, United States, 11042
Actively Recruiting
5
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
6
Vanderbilt-Ingram Cancer Institute
Nashville, Tennessee, United States, 37232
Actively Recruiting
7
University of Texas-MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
8
Lumi Research
Houston, Texas, United States, 77090
Actively Recruiting
9
Laguna Clinical Research Associates
Laredo, Texas, United States, 78041
Actively Recruiting
10
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
11
Virginia Cancer Specialists-Fairfax
Fairfax, Virginia, United States, 22031
Actively Recruiting
12
University of Wisconsin-Madison Carbone Cancer Center
Madison, Wisconsin, United States, 53706
Actively Recruiting
Research Team
M
Mark Burns, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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