Description
This phase 1b dose-escalation study is to establish the recommended phase 2 dose and to evaluate the safety of combined dosing of the BCL-XL degrader DT2216 with weekly paclitaxel in recurrent platinum-resistant ovarian cancer. DT2216 is a drug that degrades a protein called BCL-XL which helps to protect cancer cells from cell death. Paclitaxel is an anti-cancer drug that is already used for the treatment of ovarian cancer.
The U.S. Food and Drug Administration (FDA) has not approved DT2216 as a treatment for ovarian cancer.
The U.S. Food and Drug Administration (FDA) has approved paclitaxel as a treatment option for ovarian cancer, as a standalone treatment or in combination with other chemotherapy drugs, but not in combination with DT2216.
The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, Computerized Tomography (CT) scans, and electrocardiograms (ECGs).
It is expected that about 30 people will take part in this research study.
Dialectic Therapeutics is supporting this research study by providing funding and the study drug DT2216. The Department of Defense (DoD) and the American Society for Clinical Oncology are also providing funding for this study.