NCT07287917

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

A Phase 1b/2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Aminex Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, open-label Phase 1b/2 clinical trial evaluating the combination of oral AMXT 1501 and oral DFMO with standard of care (SOC) therapies in patients with advanced solid tumors who have progressed after prior therapy. AMXT 1501 is a polyamine transport inhibitor, and DFMO is an inhibitor of polyamine biosynthesis. Together, they are designed to reduce tumor polyamines and potentially improve tumor response to standard cancer treatments. Preclinical and early clinical studies suggest that dual polyamine blockade may reduce tumor growth and reverse tumor-induced immunosuppression. Cohort 1: ER+ / HER2- Breast Cancer Patients receive AMXT 1501 + DFMO in combination with: Fulvestrant 500 mg IM Capivasertib 400 mg PO BID (4 days on, 3 days off) Cohort 2: Unresectable or Metastatic Cutaneous Melanoma Patients receive AMXT 1501 + DFMO in combination with: Pembrolizumab 200 mg IV every 3 weeks Phase 1b (Safety Run-In) The primary objective is to evaluate safety, tolerability, dose-limiting toxicities (DLTs), and to identify the recommended Phase 2 dose (RP2D). A standard 3+3 dose-escalation design is used. Phase 2 (Dose Expansion) The study evaluates the efficacy of the combination regimens using: Objective response rate (ORR) Duration of response (DOR) Disease control rate (DCR) Progression-free survival (PFS) Overall survival (OS) Pharmacokinetics, pharmacodynamics, and biomarker analyses (including tumor biopsies) will also be conducted. Up to approximately 92 patients will be enrolled across the two cohorts.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-26
• Primary completion: 2028-02-28
• Completion: 2028-12-29
• First posted: 2025-12-17
• Last updated: 2026-03-12

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study