Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors (NCT07287917) | Clinical Trial Compass
RecruitingPhase 1/2
Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors
United States92 participantsStarted 2026-01-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Understand and sign the informed consent form (ICF) and be willing to comply with all study procedures before any study specific procedures are conducted.
. ≥18 years old at the time of signing the informed consent.
. Diagnosed with unresectable, locally advanced, or metastatic solid tumors including ER+ HER2- breast cancer (Cohort 1) or melanoma (Cohort 2)
. Patients must be willing to undergo a fresh tumor biopsy at Screening and during treatment if safe and clinically feasible. An archival sample is allowed if obtained within 1 year prior to the first dose of study drug. However, lack of tumor biopsy by itself will not preclude patients from enrollment.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening or Day 1.
. Life expectancy of at least 12 weeks.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Dose-Limiting Toxicities (DLTs)
Timeframe: Within 24 months of last patient enrolled
2
Incidence, Frequency, and Severity of Adverse Events (AEs)
Timeframe: Within 24 months of last patient enrolled
3
Objective Response Rate (ORR) (Phase 2)
Timeframe: Within 24 months of last patient enrolled
4
Duration of Response (DOR) (Phase 2)
Timeframe: Within 24 months of last patient enrolled
. Fully recovered from acute toxic effects of prior anti-neoplastic therapies. The following minimum periods from treatment apply:
Exclusion criteria
. Patients with melanoma only:
. Intolerant to any component of combination or standard of care therapies.
. History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. Patient has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
. Treatment with radiation therapy, surgery, chemotherapy, or immunotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or Mitomycin C). No prior use of Adriamycin is allowed. Limited prior palliative radiation may be permissible no less than 2 weeks prior to C1D1 with approval from the Sponsor Medical Monitor or designee.
. Targeted small molecule therapy within 7 days prior to initiation of trial therapy. Chemotherapy within 14 days prior to initiation of trial therapy.
. Active autoimmune disease (e.g., lupus, rheumatoid arthritis, Sjogren's syndrome) requiring systemic treatment (i.e., disease modifying agents, corticosteroids, or immunosuppressive drugs) in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
. History of or presence of clinically significant cardiovascular disease, e.g.,