Study #2025-1512
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
MD Anderson Study Status
Enrolling
Treatment Agent
AMXT 1501 Dicaprate, DFMO, Fulvestrant, Capivasertib, Pembrolizumab
Description
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.
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
Melanoma (Skin Cancer), HER2-low Hormone Receptor Positive Breast Cancer
Study phase:
Physician name:
Sarina Piha-Paul
Department:
Investigational Cancer Therapeutics
For general questions about clinical trials:
1-877-632-6789
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