NCI-2022-01323

A First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer

This is a research study that's trying out a new kind of medicine for the first time. The medicine is called RLY-2608, and it's meant to target a specific protein called PI3Kα. This protein is found in some tumors (abnormal growths) in the body. The study is being done with two groups of people: The first group has advanced tumors. These people will be given only the new medicine, RLY-2608, to see how well it works on its own. The second group has a specific type of advanced breast cancer. They will receive a combination of the new medicine, RLY-2608, and another treatment called Fulvestrant. Fulvestrant is a medicine used to treat breast cancer. The goal of this study is to find out if RLY-2608 is safe to use in people and whether it can help treat advanced tumors and breast cancer. They'll be looking at how well the medicine works in shrinking the tumors, how the patients' bodies respond, and how the patients feel during the treatment.

Advanced: Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

For more information about the trial, click the link below:

https://clinicaltrials.gov/ct2/show/NCT05216432

NCI-2022-01323

Clinical Trial Site: Columbia

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