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

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.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• 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

Locations (12)