NCT06964009

DT2216 + Paclitaxel in Platinum-Resistant Ovarian Cancer

Recruiting now Phase 1 Last updated 8 January 2026

What this trial tests

Phase 1 trial testing DT2216 in Ovarian Cancer in 30 participants. Currently enrolling.

Timeline

22 September 2025

Primary endpoint
30 December 2026

30 December 2027

Quick facts

Lead sponsor	Elizabeth Stover, MD, PhD
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	22 September 2025
Primary completion	30 December 2026
Estimated completion	30 December 2027
Sites	3 locations across United States

Drugs / interventions tested

• DT2216 — full drug profile →
• Paclitaxel — full drug profile →

Conditions studied

• Ovarian Cancer — all drugs for Ovarian Cancer →
• Ovarian Carcinoma — all drugs for Ovarian Carcinoma →
• Recurrent Ovary Cancer — all drugs for Recurrent Ovary Cancer →
• Recurrent Platinum-Resistant Ovarian Carcinoma — all drugs for Recurrent Platinum-Resistant Ovarian Carcinoma →

Sponsor

Elizabeth Stover, MD, PhD

Who can join

18 and older, female only, with Ovarian Cancer or Ovarian Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. First in human phase 1 study of DT2216, a selective BCL-xL degrader, in patients with relapsed/refractory solid malignancies.
   Mahadevan D, Barve M, Mahalingam D, Parekh J, et al · · 2025 · cited 8× · PMID 41225624 · DOI 10.1186/s13045-025-01753-8
2. Proteolysis-Targeting Chimera (PROTAC): Current Applications and Future Directions.
   Fan G, Chen S, Zhang Q, Yu N, et al · · 2025 · cited 6× · PMID 41049269 · DOI 10.1002/mco2.70401
3. E3 Ubiquitin Ligases: Structures, Biological Functions, Diseases, and Therapy.
   Wang H, Peng J, Li H, Lan Y, et al · · 2025 · cited 1× · PMID 41362701 · DOI 10.1002/mco2.70528
4. Quiescent OXPHOS-High Triple-Negative Breast Cancer Cells That Persist After Chemotherapy Depend on BCL-XL for Survival.
   Andrzejewski S, Winter M, Encarnacao Garcia L, Akinrinmade O, et al · · 2025 · cited 1× · PMID 41090785 · DOI 10.3390/cells14191557
5. The Combination of a BCL-xL PROTAC and an mTOR Inhibitor Sensitizes Pancreatic Ductal Adenocarcinoma to KRAS<sup>G12D</sup> Inhibitor Treatment.
   Miyan J, Vudatha V, Cao L, Zhang P, et al · · 2026 · PMID 41899524 · DOI 10.3390/cancers18060920
6. PROTAC-based protein degradation: a window of opportunity for melanoma therapy.
   Gentile G, D'Aguanno S, Di Martile M, Petricca A, et al · · 2026 · PMID 41761284 · DOI 10.1186/s12929-026-01225-2
7. When Targeted Therapy Falls Short: Unraveling Resistance Mechanisms in Chronic Lymphocytic Leukemia.
   Benrashid S, Woyach JA. · · 2026 · PMID 41741806 · DOI 10.1007/s11899-026-00776-3
8. PROTAC-mediated degradation of Bcl-xL potentiates target therapy in preclinical melanoma models.
   Valentini E, Gentile G, Di Martile M, D'Aguanno S, et al · · 2026 · PMID 41501884 · DOI 10.1186/s13046-025-03635-w