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AMXT 1501 Dicaprate / DFMO / HER2 Low Hormone Receptor Positive Breast Cancer · Phase 1/2 Trial
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry entry for a Phase 1b/2 trial of AMXT 1501 and DFMO combined with standard therapies in melanoma and breast cancer. No efficacy or safety results are reported; the record describes planned enrollment, study arms, and primary outcome measures only. Clinicians should await publication of results before interpreting clinical utility.
Phase 1/2, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Melanoma (Skin Cancer), HER2-low Hormone Receptor Positive Breast Cancer; age from 18 Years. Intervention: Arm 1: Breast Cancer (ER+ HER2-); Arm 2: Melanoma. n = 92. 20 sites: United States.
This is a registry entry for a Phase 1b/2 trial of AMXT 1501 and DFMO combined with standard therapies in melanoma and breast cancer. No efficacy or safety results are reported; the record describes planned enrollment, study arms, and primary outcome measures only. Clinicians should await publication of results before interpreting clinical utility.
No interim data, safety signals, or stopping rules are described in the registry entry.
The source did not state who this applies to in practice.
This is a clinical trial registry record describing a planned Phase 1b/2 study with no results reported; it documents the protocol and design only.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07287917). This is a study registration, not published results. Lead sponsor: Aminex Therapeutics, Inc.. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 92 participants (ESTIMATED). Conditions: Melanoma (Skin Cancer), HER2-low Hormone Receptor Positive Breast Cancer. Interventions: DRUG: AMXT 1501 Dicaprate; DRUG: DFMO; DRUG: Fulvestrant; DRUG: Capivasertib; DRUG: Pembrolizumab. Primary outcome measures: Incidence of Dose-Limiting Toxicities (DLTs) , Within 24 months of last patient enrolled; Incidence, Frequency, and Severity of Adverse Events (AEs) , Within 24 months of last patient enrolled; Objective Response Rate (ORR) (Phase 2) , Within 24 months of last patient enrolled; Duration of Response (DOR) (Phase 2) , Within 24 months of last patient enrolled. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.