DT2216 + Paclitaxel in Platinum-Resistant Ovarian Cancer (NCT06964009)

Usually NOT eligible if any of the following apply:

• Exclusion Criteria:
• Prior treatment with weekly paclitaxel in the recurrent setting. Prior dose-dense paclitaxel as part of the initial treatment at diagnosis is allowed.
• Prior treatment with any BCL-XL inhibitor, such as navitoclax.
• Participants who are receiving any other investigational agents for this condition or received an investigational agent within 5 half-lives of the agent or 4 weeks, whichever is shorter.
• Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) except for alopecia. Participants with endocrine- related AEs who are adequately treated with hormone replacement or participants who have grade 2 neuropathy are eligible. Participants with grade 2 anemia likely related to prior treatment are eligible. Participants with a history of a thromboembolic event who are on stable therapeutic anticoagulation are eligible. Participants with asymptomatic grade 2 hypertension controlled with anti-hypertensive medications are eligible.
• Ongoing treatment with chronic immunosuppressants or systemic steroids \> 10 mg of prednisone daily (or equivalent). 10 mg daily of oral prednisone or less can be continued if clinically required.
• Known active central nervous system involvement with metastatic cancer, including leptomeningeal disease. Participants with previously treated brain metastases may enroll if the disease is stable for at least one month on imaging with no neurologic symptoms and participants are not receiving pharmacologic doses of glucocorticoids for this diagnosis.
• Prior organ transplantation or other cellular therapies such as Chimeric Antigen Receptor T-cells. Prior allogeneic stem cell transplantation (SCT) is allowed if there is no evidence of Graft Versus Host Disease and if participant meets other eligibility criteria listed. Prior autologous SCT is permitted if the participant meets the other eligibility criteria listed.
• History of major surgery within 8 weeks prior to first dose of study drug.
• History of clinically significant small or large bowel obstruction within 8 weeks prior to first dose of study drug (e.g. symptomatic, impairing nutrition, requiring nasogastric tube, requiring hospital admission).
• History of clinically significant ascites or pleural effusion requiring recurrent paracentesis or thoracentesis within 4 weeks prior to first dose of study drug.
• Dependence upon TPN or regular IV fluid resuscitation.