AMXT 1501 Dicaprate

1 clinical trials involving this therapy/drug

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Descriptions are automatically translated with AI assistance. Always verify details in the original on ClinicalTrials.gov and consult your treating physician.

RecruitingPhase I/IIBreast cancerMelanomaHormone receptor positive (HR+)Metastatic / advanced

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

NCT07287917ClinicalTrials.gov ↗

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.

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