The purpose of this research study is determining the highest dose of the study drug DT2216 in combination with paclitaxel that can be safely and tolerably administered in recurrent ovarian cancer.
The names of the study drugs involved in this study are:
* DT2216 (a type of proteolysis-targeting chimera degrader of BCL-XL protein) * Paclitaxel (a type of antimicrotubule agent)
Participants must have histologically confirmed relapsed or refractory ovarian cancer (including epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma).
Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non- nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.
Participants must have received at least one prior platinum-based chemotherapeutic regimen for primary management of disease.
Participants must have been treated with at least one line of standard-of-care platinum-based chemotherapy but otherwise there is no limit on lines of prior systemic therapy. For participants who received recent palliative radiotherapy, the radiation treatment must have been completed at least two weeks prior to initiating study treatment. Prior dose-dense paclitaxel as part of initial treatment and prior treatment with weekly paclitaxel in the recurrent setting is permitted; however, at least 6 months must have elapsed between the last dose of weekly paclitaxel and protocol treatment initiation.
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.
Elizabeth Stover, MD, PhD
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
United States Department of Defense
Collaborator
Dialectic Therapeutics, Inc
Collaborator
American Society of Clinical Oncology
Collaborator