A Phase 1b Study of BCL-XL Degrader DT2216 in Combination With Weekly Paclitaxel in Recurrent Platinum-resistant Ovarian Cancer
Elizabeth Stover, MD, PhD
Summary
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)
Description
This phase 1b dose-escalation study is to establish the recommended phase 2 dose and to evaluate the safety of combined dosing of the BCL-XL degrader DT2216 with weekly paclitaxel in recurrent platinum-resistant ovarian cancer. DT2216 is a drug that degrades a protein called BCL-XL which helps to protect cancer cells from cell death. Paclitaxel is an anti-cancer drug that is already used for the treatment of ovarian cancer. The U.S. Food and Drug Administration (FDA) has not approved DT2216 as a treatment for ovarian cancer. The U.S. Food and Drug Administration (FDA) has approved paclitaxel…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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-base…
Interventions
- DrugDT2216
A proteolysis-targeting chimera (PROTAC) degrader, single-use vial, via intravenous (into the vein) infusion.
- DrugPaclitaxel
An antimicrotubule agent, multi-dose vial, via intravenous (into the vein) infusion per institutional standard.
Locations (3)
- Beth Israel Deaconess Medical Center (BIDMC)Boston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts
- Brigham and Women's HospitalBoston, Massachusetts