Testing a new cancer drug alone and with hormone therapy

Plain-English translation of NCT07288359 on ClinicalTrials.gov ↗ · Source last updated October 2026 · Translation generated August 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 new drug called to see if it can help people with advanced cancers, particularly hormone receptor-positive breast cancer and castration-resistant prostate cancer. The medication will be tested on its own and also combined with standard hormone therapy drugs to find the safest and most effective doses and combinations. Researchers want to understand how well this treatment works and what side effects people experience.

Many patients with advanced breast cancer and prostate cancer eventually stop responding to current treatments. This trial exists to explore whether this medication might offer a new option for people whose cancers have progressed despite existing therapies.

Do you qualify?

You likely qualify if…

you are 18 years or older
you have been diagnosed with advanced hormone receptor-positive breast cancer that has progressed despite hormone therapy and a type of drug called a CDK4/6 inhibitor, or you have metastatic prostate cancer that no longer responds to hormone therapy
you have received a limited number of prior treatments (depending on which part of the study you join)
you have measurable disease that can be tracked on imaging scans
you have adequate bone marrow and organ function based on blood tests

You likely don't qualify if…

you have significant heart disease, irregular heartbeat patterns, or a history of heart attack
you have untreated cancer that has spread to your brain or brain metastases requiring ongoing treatment
you have serious organ involvement from your cancer causing immediate life-threatening complications
you are pregnant, nursing, or unwilling to use effective birth control during the study
you have severely abnormal blood counts or organ function on laboratory tests

What participation looks like

You would visit the study center regularly to receive the medication (by mouth or injection, depending on which treatment arm you join) and undergo blood tests and imaging scans to monitor how you're responding. The study has two main phases: the first focuses on finding the right dose, and the second tests how well the medication works. Your participation would continue as long as the treatment is helping and you are tolerating it well.

AI-generated summary from trial data · Aug 8, 2026 · Not medical advice

Trial locations(16 sites)

United States

Emory University, Atlanta, Georgia

Tennessee Oncology PLLC, Nashville, Tennessee

START, San Antonio, Texas

Canada

Novartis Investigative Site, Toronto, Ontario

Czechia

Novartis Investigative Site, Olomouc