Actively Recruiting
DT2216 + Paclitaxel in Platinum-Resistant Ovarian Cancer
Led by Elizabeth Stover, MD, PhD · Updated on 2026-04-21
30
Participants Needed
3
Research Sites
118 weeks
Total Duration
On this page
Sponsors
E
Elizabeth Stover, MD, PhD
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
DT2216 + Paclitaxel in Platinum-Resistant Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed relapsed or refractory ovarian cancer, including epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
- Measurable disease with at least one lesion ≥20 mm by chest x-ray or ≥10 mm by CT, MRI, or clinical exam
- Received at least one prior platinum-based chemotherapy regimen for disease management
- Prior dose-dense paclitaxel allowed; prior weekly paclitaxel in recurrent setting allowed if last dose was at least 6 months before study start
- Age 18 years or older
- ECOG performance status 0 to 2
- Meet specific lab criteria for neutrophils, platelets, hemoglobin, bilirubin, liver enzymes, clotting times, albumin, and kidney function
- For participants with HIV, meet defined immune and treatment criteria
- Past hepatitis B or C infections treated with undetectable viral levels
- Prior or concurrent malignancies allowed if stable and not interfering with study
- Platinum-resistant disease defined by progression within 6 months after last platinum dose
- Epithelial ovarian cancer of any histology
- Females of childbearing potential must agree to use adequate contraception during and for 3 months after study
- Ability and willingness to sign informed consent
You will not qualify if you...
- Prior weekly paclitaxel treatment in recurrent setting (except allowed prior dose-dense paclitaxel at diagnosis)
- Prior treatment with any BCL-XL inhibitor such as navitoclax
- Receiving or recently received (within 5 half-lives or 4 weeks) other investigational agents
- Unrecovered adverse effects from prior cancer therapy greater than grade 1 (with some exceptions)
- Use of chronic immunosuppressants or systemic steroids over 10 mg prednisone daily
- Active central nervous system metastatic cancer or unstable brain metastases
- Prior organ transplant or certain cellular therapies (with some exceptions for stem cell transplant)
- Major surgery within 8 weeks before study drug
- Significant bowel obstruction or ascites/pleural effusion requiring repeated drainage recently
- Dependence on total parenteral nutrition or regular IV fluids
- Recent active infections (grade 2 or higher within 2 weeks before treatment)
- Prolonged QTc interval or history of Long QT Syndrome
- Recent bleeding complications or significant bleeding risk
- Uncontrolled illnesses limiting suitability for study
- Known allergies to DT2216, paclitaxel, or related compounds
- Use of strong inhibitors or inducers of CYP3A4 or CYP2C8 enzymes
- Pregnant or breastfeeding females, or those who test positive for pregnancy at screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
Research Team
E
Elizabeth Stover, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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