NCT06964009

DT2216 + Paclitaxel in Platinum-Resistant Ovarian Cancer

A Phase 1b Study of BCL-XL Degrader DT2216 in Combination With Weekly Paclitaxel in Recurrent Platinum-resistant Ovarian Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Elizabeth Stover, MD, PhD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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 as a treatment option for ovarian cancer, as a standalone treatment or in combination with other chemotherapy drugs, but not in combination with DT2216. The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, Computerized Tomography (CT) scans, and electrocardiograms (ECGs). It is expected that about 30 people will take part in this research study. Dialectic Therapeutics is supporting this research study by providing funding and the study drug DT2216. The Department of Defense (DoD) and the American Society for Clinical Oncology are also providing funding for this study.

Conditions

• Ovarian Cancer
• Ovarian Carcinoma
• Recurrent Ovary Cancer
• Recurrent Platinum-Resistant Ovarian Carcinoma

Interventions

Type	Name	Description
DRUG	DT2216	A proteolysis-targeting chimera (PROTAC) degrader, single-use vial, via intravenous (into the vein) infusion.
DRUG	Paclitaxel	An antimicrotubule agent, multi-dose vial, via intravenous (into the vein) infusion per institutional standard.

Timeline

• Start date: 2025-09-22
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2025-05-09
• Last updated: 2026-01-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study