Actively Recruiting
A Phase 1b Study of BCL-XL Degrader DT2216 Combined With Weekly Paclitaxel in Recurrent Platinum-Resistant Ovarian Cancer
Led by Elizabeth Stover, MD, PhD · Updated on 2026-04-21
30
Participants Needed
3
Research Sites
52 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
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.
CONDITIONS
Brief Title
DT2216 + Paclitaxel in Platinum-Resistant Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with at least one lesion meeting size requirements by imaging or clinical exam.
- Participants must have received at least one prior platinum-based chemotherapy regimen.
- Prior dose-dense paclitaxel at diagnosis and prior weekly paclitaxel in recurrence allowed if at least 6 months since last dose.
- Age 18 years or older.
- ECOG performance status 0-2.
- Meet specific laboratory criteria for blood counts, liver and kidney function.
- Participants with HIV must have CD4 count ≥300/µL, undetectable viral load, be on antiretroviral therapy, and no AIDS-defining infections in past 12 months.
- Participants with treated Hepatitis B or C must have undetectable virus levels.
- Prior or concurrent malignancies allowed if stable and not interfering with study.
- Platinum-resistant disease defined by progression within 6 months from last platinum dose.
- Must have epithelial ovarian cancer of any histology.
- Females of childbearing potential must agree to use effective contraception during and for 3 months after study.
- Ability and willingness to provide informed consent.
You will not qualify if you...
- Prior weekly paclitaxel treatment in the recurrent setting.
- Prior treatment with any BCL-XL inhibitor.
- Receiving other investigational agents or within 5 half-lives or 4 weeks.
- Unresolved side effects from prior cancer therapy greater than Grade 1 except alopecia.
- Ongoing treatment with chronic immunosuppressants or systemic steroids above 10 mg prednisone daily.
- Active central nervous system metastases or leptomeningeal disease.
- Prior organ transplantation or certain cellular therapies, except permitted stem cell transplantation.
- Major surgery within 8 weeks before starting study drug.
- Significant bowel obstruction or ascites requiring frequent drainage recently.
- Dependence on total parenteral nutrition or regular IV fluids.
- Active infections Grade 2 or higher within 2 weeks before treatment.
- Prolonged QTc interval or history of Long QT Syndrome.
- Recent bleeding complications or bleeding disorders.
- Uncontrolled serious illnesses or psychiatric conditions limiting study compliance.
- Allergic reactions to similar compounds or paclitaxel unless desensitization possible.
- Use of strong CYP3A4 or CYP2C8 inhibitors or inducers within 2 weeks before dosing.
- Pregnant or breastfeeding females; must have negative pregnancy tests and appropriate contraception.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable duration with repeated 28-day cycles until disease progression or discontinuation
Participants receive a combination of the BCL-XL degrader DT2216 and paclitaxel through intravenous infusions in 28-day cycles. Dosing includes daily DT2216 on specific days and paclitaxel on Days 1, 8, and 15 of each cycle. Participants undergo regular blood tests, ECGs, and imaging to monitor safety and treatment effects.
Weekly visits during each 28-day cycle with ECGs on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycle 2; imaging every 8 weeks during treatment
Duration - 30 days
After treatment ends, participants attend a 30-day follow-up visit to assess safety and outcomes.
1 visit (in-person)
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
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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