NCI-2022-08654

A Phase 1b Open-Label Multicenter Study of OP-1250 in Combination With the CDK4/6 Inhibitor Ribociclib or With the PI3K Inhibitor Alpelisib in Adult Subjects With Advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer

This is a research study of a new treatment for breast cancer. The treatment is a combination of two drugs: OP-1250: This is a new drug that is being tested for the first time in humans. It is a type of drug called an estrogen receptor antagonist. This means that it blocks the effects of estrogen on cancer cells. Ribociclib or Alpelisib: These are two drugs that are already approved for the treatment of some types of breast cancer. They work by blocking different pathways that cancer cells use to grow and divide. The trial is being conducted in two parts: Part 1 (Dose Escalation): This part of the trial will enroll a small number of patients to find the safest dose of OP-1250. Part 2 (Expansion): Once a safe dose is found, more patients will be enrolled in the trial to see if the combination of OP-1250 and ribociclib or alpelisib is effective in treating breast cancer. The trial is only for patients with advanced or metastatic HR-positive, HER2-negative breast cancer. This means that the cancer has spread from where it started to other parts of the body, and it is positive for the estrogen and progesterone receptors but negative for the HER2 protein.

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

https://clinicaltrials.gov/ct2/show/NCT05508906

NCI-2022-08654

Clinical Trial Site: Sinai

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