Phase 1b Study of the BCL-XL Degrader DT2216 Combined with Weekly Paclitaxel for Women with Recurrent Platinum-Resistant Ovarian Cancer

What this Trial Is About

Researchers are evaluating the highest safe and tolerable dose of the study drug DT2216 when combined with paclitaxel in women with recurrent platinum-resistant ovarian cancer. This phase 1b trial aims to establish the recommended dose for future studies and assess safety. DT2216 is a new drug that targets and degrades the BCL-XL protein, which helps cancer cells avoid death, while paclitaxel is an already approved chemotherapy drug for ovarian cancer. Participants will receive both drugs in cycles lasting 28 days. DT2216 is given daily on specific days of each cycle, and paclitaxel is administered weekly on days 1, 8, and 15. The study uses a dose escalation and de-escalation design guided by a Bayesian Optimal Interval method to find the best dose combination. The trial includes baseline assessments, imaging every two cycles, ECGs and blood samples on multiple days during the first cycle and subsequent cycles, an end-of-treatment imaging visit, and a 30-day follow-up visit. During the study, participants will undergo blood and urine tests, CT scans, and ECGs to monitor their health and response to treatment. Researchers will track the maximum tolerated dose of DT2216, any dose-limiting toxicities, and treatment-related side effects. They will also assess tumor response, progression-free survival, and duration of response through imaging every eight weeks while on treatment and less frequently afterward. Participation involves regular clinic visits and monitoring for up to 24 treatment cycles or longer until disease progression or other reasons for stopping treatment.

DT2216 + Paclitaxel in Platinum-Resistant Ovarian Cancer