A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3789 as Monotherapy and in Combination with Docetaxel in Participants with Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation

Contact:

NCT Number:

Protocol:

AAAU8369

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I

The purpose of this research study is to test the safety of an investigational drug, PRT3789, at different dose levels to find out what effects, good and/or bad, PRT3789 has on Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation. Mutations are changes or alterations in the DNA (genetic material) of your cells. A SMARCA4 mutation has been linked to certain cancers. Investigational means that the study drug is currently being tested and has not been approved for use by any health authority such as the United States (US) Food and Drug Administration (FDA) or any other health or regulatory authority in other countries for the treatment of cancer. The study drug, PRT3789, is a SMARCA2 degrader meaning that it may help break down the protein called SMARCA2. This protein is part of a cell life cycle that allows tumor cells to grow and spread. When SMARCA2 breaks down, it causes tumor cells to stop progressing through their life cycle and die. Studies done in animals have shown that PRT3789 can help break down this protein and induce cancer cell death, but PRT3789 has not yet been tested in humans.

Are you Eligible? (Inclusion Criteria)

  • You are 18 years or older - You are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations such as contraception requirements, and other study procedures, including providing informed consent. - You do not have clinically significant or uncontrolled cardiac disease

Specialty Area(s)

Bladder Cancer , Breast Cancer, Colon and Rectal Cancer, Esophageal Cancer, Gynecologic Cancers, Cervical Cancer, Ovarian Cancer, Uterine (Endometrial) Cancer, Head and Neck/Oral Cancers, Kidney Cancer/Adrenal Cancer, Liver Cancer, Lung cancer, Prostate Cancer, Thyroid Cancer

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032