A New Drug, DT2216, Combined With Paclitaxel for Recurrent Platinum-Resistant Ovarian Cancer

About the Study

This study is testing a new drug called DT2216 in combination with the chemotherapy drug paclitaxel for people whose ovarian cancer has returned and no longer responds to platinum-based chemotherapy.

DT2216 is designed to target a protein called BCL-XL that helps cancer cells survive. Researchers want to find out whether combining DT2216 with paclitaxel is safe and what dose of DT2216 can be given safely with paclitaxel.

This is a phase 1b study. The main goal of an early-phase study is to learn about the safety of a new treatment and determine the dose that should be studied in future clinical trials. Researchers will also look for signs that the treatment may help control the cancer.

What the Study Involves

Everyone in the study will receive DT2216 and paclitaxel.

Treatment is given in 28-day cycles:

• DT2216 is given through a vein twice a week.
• Paclitaxel is given through a vein once a week.
• Participants will have regular blood tests and other tests to monitor their health and look for side effects.
• Imaging scans will be done about every two treatment cycles to see how the cancer is responding.
• Participants will also have electrocardiograms (ECGs) during the first treatment cycle and at the beginning of the second cycle.
• Researchers will collect blood samples during treatment to study how DT2216 affects the body.

Treatment can continue as long as the participant is benefiting and able to tolerate the study drugs.

People may be able to join this study if all of following apply:

• Are 18 or older.
• Have ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has returned or continued to grow after treatment.
• Have platinum-resistant cancer, meaning the cancer returned or progressed within 6 months after the most recent platinum-based chemotherapy.
• Have received at least one prior platinum-based chemotherapy treatment.
• Have measurable cancer that can be seen and measured on imaging or during a physical examination.
• Have an adequate level of blood counts and organ function to safely receive the study drugs.

People generally cannot join if they:

• Previously received weekly paclitaxel for recurrent cancer, unless enough time has passed according to the study requirements.
• Previously received a drug that targets BCL-XL, such as navitoclax.
• Have certain serious or uncontrolled medical conditions that could make treatment unsafe.
• Have active cancer that has spread to the brain or spinal fluid, with limited exceptions for previously treated and stable brain metastases.
• Recently had major surgery or certain serious complications such as a bowel obstruction.
• Have significant ongoing fluid buildup in the abdomen or around the lungs requiring repeated drainage.
• Are pregnant or breastfeeding.
• Are taking certain medications that could interact with the study drugs.