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 range18 Years

SexALL

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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.
✓. Adequate organ function defined as:
✓. Fully recovered from acute toxic effects of prior anti-neoplastic therapies. The following minimum periods from treatment apply:

Exclusion criteria

What they're measuring

Incidence of Dose-Limiting Toxicities (DLTs)

Timeframe: Within 24 months of last patient enrolled

Incidence, Frequency, and Severity of Adverse Events (AEs)

Timeframe: Within 24 months of last patient enrolled

Objective Response Rate (ORR) (Phase 2)

Timeframe: Within 24 months of last patient enrolled

Duration of Response (DOR) (Phase 2)

Timeframe: Within 24 months of last patient enrolled

Trial details

NCT IDNCT07287917

SponsorAminex Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-02-28

Contact for this trial

Mark Burns, PhD

425-524-1615 mburns@aminextx.com

View on ClinicalTrials.gov More Melanoma (Skin Cancer) trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

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.
✓. Adequate organ function defined as:
✓. Fully recovered from acute toxic effects of prior anti-neoplastic therapies. The following minimum periods from treatment apply:

Exclusion criteria

What they're measuring

Incidence of Dose-Limiting Toxicities (DLTs)

Timeframe: Within 24 months of last patient enrolled

Incidence, Frequency, and Severity of Adverse Events (AEs)

Timeframe: Within 24 months of last patient enrolled

Objective Response Rate (ORR) (Phase 2)

Timeframe: Within 24 months of last patient enrolled

Duration of Response (DOR) (Phase 2)

Timeframe: Within 24 months of last patient enrolled