Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Aminex Therapeutics, Inc.
Study ID
NCT07287917
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • HER2-low Hormone Receptor Positive Breast Cancer
  • Melanoma (Skin Cancer)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AMXT 1501 Dicaprate — DRUG
    Formulation: Enteric-coated oral tablet (100 mg base) Dose: Body-surface-area-adjusted; starting dose = 300 mg PO BID; may escalate per 3 + 3 design Administration: By mouth on an empty stomach (AM and PM doses)
  • DFMO — DRUG
    Formulation: 500 mg gel capsule Dose: 500 mg PO once or twice daily, per cohort dose level
  • Fulvestrant — DRUG
    Dose: 500 mg IM injection on Day 2 and Day 15 of Cycle 1, then Day 2 of each subsequent 28-day cycle
  • Capivasertib — DRUG
    Dose: 400 mg PO BID for 4 days on / 3 days off each week (28-day cycle)
  • Pembrolizumab — DRUG
    200 mg IV infusion every 3 weeks (Q3W) for up to 12 months

Study Details

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.

Key Dates

Start date
Jan 26, 2026
Status verified
May 2026
Primary completion
Feb 28, 2028
Completion
Dec 29, 2028

Study Design

Enrollment
92 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Breast Cancer (ER+ HER2-)
    Arm 1: Breast Cancer Cohort (Cohort 1: ER+ / HER2-) AMXT 1501 oral DFMO oral Fulvestrant IM Capivasertib PO
  • Experimental: Arm 2: Melanoma
    Arm 2: Melanoma Cohort (Cohort 2: Melanoma) AMXT 1501 oral DFMO oral Pembrolizumab IV

Primary Outcome Measure

Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: Within 24 months of last patient enrolled ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
START Los AngelesLos AngelesCalifornia90025
Meribeth DePerio
[email protected]
424-465-1820
Lasika Seneviratne, MD (PRINCIPAL_INVESTIGATOR)
Skin Cancer InstituteEnglewoodColorado80113
Sydney Harris
[email protected]
720-316-8091
Ryan Weight, MD (PRINCIPAL_INVESTIGATOR)
Wayne State University - Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201
Madeline Alvarez
[email protected]
313-576-6769
Yusra Shao, MD (PRINCIPAL_INVESTIGATOR)
START Cancer Research New York-Long IslandLake SuccessNew York11042
Sadia Morium
[email protected]
363-207-5160
Geraldine Coyne, MD (PRINCIPAL_INVESTIGATOR)
University of Cincinnati Medical CenterCincinnatiOhio45219
Kayla Webb
[email protected]
513-584-0599
Jennifer Leddon, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt-Ingram Cancer InstituteNashvilleTennessee37232
Douglas Johnson, MD
[email protected]
615-936-8422
Douglas Johnson, MD (PRINCIPAL_INVESTIGATOR)
Lumi ResearchHoustonTexas77090
Kolin Kabbes, MS
[email protected]
8326152755
Bhavin Shah, BS
[email protected]
832-279-5111
David Nguyen, MD (PRINCIPAL_INVESTIGATOR)
University of Texas-MD AndersonHoustonTexas77030
Celia Mak
[email protected]
713-745-3282
Mona Moawad
[email protected]
346-720-0464
Sarina Piha-Paul, MD (PRINCIPAL_INVESTIGATOR)
Laguna Clinical Research AssociatesLaredoTexas78041
Alex Guerrero, BS
[email protected]
956-693-1301
Veronica Procasky, BS
[email protected]
713-775-9892
Eduardo Miranda, MD (PRINCIPAL_INVESTIGATOR)
START Mountain RegionWest Valley CityUtah84119
Shontay Conway
[email protected]
801-907-4772
Justin Call, MD (PRINCIPAL_INVESTIGATOR)
Virginia Cancer Specialists-FairfaxFairfaxVirginia22031
Syed Hasan
[email protected]
703-783-4510
Mohamed Skaleni, MD (PRINCIPAL_INVESTIGATOR)
University of Wisconsin-Madison Carbone Cancer CenterMadisonWisconsin53706
Kathryn Hermann
[email protected]
608-265-2546
Vincent Ma, MD (PRINCIPAL_INVESTIGATOR)

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START Los Angeles· Los Angeles, CASkin Cancer Institute· Englewood, COWayne State University - Barbara Ann Karmanos Cancer Institute· Detroit, MISTART Cancer Research New York-Long Island· Lake Success, NYUniversity of Cincinnati Medical Center· Cincinnati, OHVanderbilt-Ingram Cancer Institute· Nashville, TN

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