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

NCT07287917 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

AMXT 1501 Dicaprate

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)

DRUG

DFMO

Formulation: 500 mg gel capsule Dose: 500 mg PO once or twice daily, per cohort dose level

DRUG

Fulvestrant

Dose: 500 mg IM injection on Day 2 and Day 15 of Cycle 1, then Day 2 of each subsequent 28-day cycle

DRUG

Capivasertib

Dose: 400 mg PO BID for 4 days on / 3 days off each week (28-day cycle)

DRUG

Pembrolizumab

200 mg IV infusion every 3 weeks (Q3W) for up to 12 months

Sponsors & Collaborators

  • Aminex Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Deyaa Adib, MD · Aminex Therapeutics, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-26
Primary Completion
2028-02-28
Completion
2028-12-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07287917 on ClinicalTrials.gov