Study of AMXT 1501 and DFMO for Advanced Solid Tumors
This study is testing two new drugs, AMXT 1501 and DFMO, alongside standard treatments for advanced solid tumors. It aims to see how safe they are, if you can tolerate them, and if they help shrink tumors. The study includes people with HER2-low hormone receptor positive breast cancer (ER+/HER2- breast cancer) or melanoma (skin cancer). Researchers will combine AMXT 1501 and DFMO with either fulvestrant and capivasertib for breast cancer, or pembrolizumab for melanoma. The study will also look at how the drugs move through your body and affect your disease. You may be eligible if you are 18 or older and meet specific criteria for your cancer type.
- Study design
- This is an open-label (meaning you and your doctors will know what treatments you are receiving) Phase 1b/2 study, planning to enroll 92 participants. The Phase 1b part will determine the best dose, and the Phase 2 part will further evaluate how well the treatment works.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track side effects and how well the treatment works for up to 24 months after the last patient joins the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors
At a glance
Conditions
Where it's being run
17 sites across 12 statesStudy leadership
- Deyaa Adib, MD · STUDY_DIRECTOR · Aminex Therapeutics, Inc.
Who to contact
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What this trial measures
- Incidence of Dose-Limiting Toxicities (DLTs)Within 24 months of last patient enrolled
Number of participants experiencing dose-limiting toxicities as defined in the protocol, including hematologic and non-hematologic toxicities, treatment-related dosing delays, missed doses, or any toxicity leading to discontinuation during the DLT evaluation period.
- Incidence, Frequency, and Severity of Adverse Events (AEs)Within 24 months of last patient enrolled
Assessment of all treatment-emergent adverse events graded using CTCAE v5.0, including clinical labs, vital signs, ECGs, cardiac biomarkers, and physical examinations, to evaluate the safety and tolerability of AMXT 1501 + DFMO with SOC.
- Objective Response Rate (ORR) (Phase 2)Within 24 months of last patient enrolled
Proportion of participants achieving a confirmed Complete Response (CR) or Partial Response (PR) per RECIST v1.1 as assessed by the investigator.
- Duration of Response (DOR) (Phase 2)Within 24 months of last patient enrolled
Duration for which a patient maintains a confirmed objective response per RECIST v1.1.