Study of AMXT 1501 and DFMO with Standard Treatments for Advanced Solid Tumors
Sponsor: Aminex Therapeutics, Inc.
ClinicalTrials ID:NCT07287917
This clinical trial is testing the safety and early effectiveness of combining two new drugs, AMXT 1501 and DFMO, with standard treatments for advanced solid tumors. The study involves two groups: one with breast cancer patients and another with melanoma patients.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to evaluate how safe and tolerable the combination of AMXT 1501 and DFMO is when used with standard cancer treatments for advanced solid tumors. It includes two groups: one for patients with ER+ / HER2- breast cancer receiving fulvestrant and capivasertib, and another for patients with advanced melanoma receiving pembrolizumab. The first phase will determine the best dose for further testing, while the second phase will assess how well the treatment works using specific criteria for tumor response.
Description
This clinical trial is being conducted at multiple centers and is open-label, meaning both doctors and participants know what treatment is being given. It is divided into two phases: Phase 1b and Phase 2.
In Phase 1b, the focus is on finding a safe and tolerable dose of AMXT 1501 and DFMO when combined with standard treatments. This phase uses a method to gradually increase doses to find the best one for further testing.
In Phase 2, the study will look at how effective the treatment is by measuring things like how much the tumors shrink, how long the response lasts, and overall survival rates. Researchers will also study how the drugs move through and affect the body.
The study involves two groups:
- Cohort 1: Patients with ER+ / HER2- breast cancer will receive AMXT 1501 and DFMO along with fulvestrant and capivasertib.
- Cohort 2: Patients with advanced melanoma will receive AMXT 1501 and DFMO along with pembrolizumab.
Up to 92 patients will participate across both groups. The study will also involve collecting tumor samples and conducting various tests to understand the treatment's effects better.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have advanced solid tumors, specifically ER+ HER2- breast cancer or melanoma.
- For breast cancer patients: Must have specific genetic changes and have tried at least two other treatments.
- For melanoma patients: Must have tried immune checkpoint inhibitors and, if applicable, BRAF or MEK inhibitors.
- Must have measurable disease and be willing to provide tumor samples.
- Must have good overall health and organ function.
- Must be willing to use effective birth control during the study and for a period after.
- Must be able to take oral medications.
Exclusion Criteria
- Cannot have had recent cancer treatments or unresolved side effects from previous treatments.
- Cannot have active infections or autoimmune diseases requiring treatment.
- Cannot have significant heart or lung conditions.
- Cannot be pregnant or breastfeeding.
- Cannot have other active cancers requiring treatment.
- Cannot have a history of severe allergic reactions to study drugs.
- Cannot be taking certain medications or supplements that interfere with the study drugs.
- Cannot have uncontrolled infections or other serious health conditions.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| START Los Angeles | 90025 | Los Angeles | California |
| START Cancer Research New York-Long Island | 11042 | Lake Success | New York |
| University of Texas-MD Anderson | 77030 | Houston | Texas |
| Lumi Research | 77090 | Houston | Texas |
| Laguna Clinical Research Associates | 78041 | Laredo | Texas |
| START Mountain Region | 84119 | West Valley City | Utah |
| Virginia Cancer Specialists-Fairfax | 22031 | Fairfax | Virginia |
| University of Wisconsin-Madison Carbone Cancer Center | 53706 | Madison | Wisconsin |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.