NCI-2023-02845

A Phase 1 Dose Escalation and Expansion Open-label, Multicenter, Study of OP-1250 in Combination With the CDK4/6 Inhibitor Palbociclib in Adult Subjects With Advanced or Metastatic HR-positive, HER2-negative Breast Cancer

This is a research study where scientists want to see if two different medicines can help people with Hormone Receptor-positive, HER2-negative breast cancer. The first medicine is called OP-1250. It's a new kind of medicine that fights against cancer. The second medicine is called palbociclib. It's a medicine that helps stop the cancer from growing. The scientists want to find out if these two medicines, when used together, are safe and if they work well against this type of breast cancer. They will give these medicines to adults who have advanced or metastatic breast cancer, which means the cancer has spread. The study wants to see if the two medicines can be given safely together and how much of each medicine people can take without getting too sick. They also want to see if the medicines can help shrink the cancer and make people feel better.

Hormone Receptor-Positive: It is a type of breast cancer where the cancer cells have receptors on their surface that can attach to hormones in the body, particularly estrogen and/or progesterone. When these receptors attach to hormones, they can stimulate the cancer cells to grow.

HER-2 Negative: It is a type of breast cancer where cancer cells have normal levels of the protein called HER-2. Cancer cells that are HER-2 negative grow more slowly and are less likely come back or spread to other parts of the body than cancers that have too much HER-2.

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.

Metastatic: cancer that has spread from its original location or organ to other parts of the body.

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

https://clinicaltrials.gov/ct2/show/NCT05266105

NCI-2023-02845

Clinical Trial Site: Columbia

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