Protocol No.UW25111
AMXT1501-103
Principal InvestigatorMa, Vincent
PhaseI/II
Age GroupAdult
ClinicalTrials.GovNCT07287917 (Click to jump to clinicaltrials.gov)
Management Group(s) Early Phase

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

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.

Objective
Phase 1b (Safety Run-In) Primary Objective:
-To evaluate the safety and tolerability and to identify the RP2D of AMXT 1501 in combination with DFMO and with SOC in patients with advanced recurrent solid tumors.

Phase 1b (Safety Run-In) Secondary Objectives:
-To determine the efficacy of AMXT 1501 in combination with DFMO and with SOC in patients with advanced recurrent solid tumors.
-To evaluate the steady-state PK of AMXT 1501 and DFMO.

Phase 2 (Dose Expansion) Primary Objectives:
-To determine the efficacy of AMXT 1501 in combination with DFMO and with SOC in patients with advanced recurrent solid tumors.
-To evaluate the safety and tolerability of AMXT 1501 in combination with DFMO and with SOC in patients with advanced recurrent solid tumors.

Phase 2 (Dose Expansion) Secondary Objectives:
-To evaluate the steady-state PK of AMXT 1501 and DFMO.

Treatment his 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 Eligibility For full study eligibility, see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Breast; Melanoma/Skin cancer

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital