Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: Patients will be eligible for study participation only if they meet ALL the inclusion criteria applicable to their diagnosis. 1. Understand and sign the informed consent form (ICF) and be willing to comply with all study procedures before any study specific procedures are conducted. 2. ≥18 years old at the time of signing the informed consent. 3. Diagnosed with unresectable, locally advanced, or metastatic solid tumors including ER+ HER2- breast cancer (Cohort 1) or melanoma (Cohort 2) a.Underlying malignant disease must be histologically or cytologically documented b.For breast cancer patients: locally advanced or metastatic breast cancer with one or more actionable PIK3CA/AKT1/PTEN-alterations following progression on at least 2 endocrine-based regimens in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. Patients who are candidates to start therapy with capivasertib are eligible for enrollment. Patients previously treated