Recruiting

Testing two new medications combined with standard cancer treatments

Plain-English translation of NCT07287917 on ClinicalTrials.gov ↗ · Source last updated May 2026 · Translation generated June 2026 · How we translate trials

Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.

What is this trial?

This study is testing a combination of two oral medications called AMXT 1501 and alongside your regular cancer treatment. These medications work together to target cancer cells by reducing a substance called polyamine that tumors need to grow. The hope is that this combination will help your cancer respond better to standard therapies like immunotherapy or hormone-based treatments.

Many patients with advanced breast cancer or melanoma eventually stop responding to their current treatments. Early research suggests that this medication combination may help reverse the resistance tumors develop and boost your immune system's ability to fight cancer.

Do you qualify?

You likely qualify if…

you are 18 years old or older
you have been diagnosed with advanced breast cancer (hormone receptor positive, HER2 negative) that has progressed after at least two prior treatments, OR unresectable/metastatic melanoma that has progressed after immune checkpoint inhibitor therapy
you have genetic mutations (PIK3CA, AKT1, or PTEN) in your breast cancer, or for melanoma, you have progressed on appropriate prior therapies including immunotherapy and BRAF/MEK inhibitors if applicable
you have measurable disease that can be tracked on imaging scans
you are willing to sign an informed consent form and follow all study procedures

You likely don't qualify if…

you have untreated brain metastases or severe organ dysfunction
you are pregnant or breastfeeding
you have active or unresolved severe side effects from prior immunotherapy treatments
you are unable to take oral medications

What participation looks like

You would take two oral medications daily at home while continuing your standard cancer treatment (either hormone therapy with an additional drug for breast cancer, or immunotherapy infusions every three weeks for melanoma). You would attend regular clinic visits for blood tests, imaging scans, and tumor biopsies to monitor how well the treatment is working and watch for side effects. The study has an initial safety phase to find the right dose, followed by an expansion phase to test how well the combination works.

AI-generated summary from trial data · Jun 15, 2026 · Not medical advice

Testing two new medications combined with standard cancer treatments

What is this trial?

Do you qualify?

What participation looks like

Trial locations(12 sites)