OncoMatch/Clinical Trials/NCT06964009
DT2216 + Paclitaxel in Platinum-Resistant Ovarian Cancer
Is NCT06964009 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including DT2216 and Paclitaxel for ovarian cancer.
Treatment: DT2216 · Paclitaxel — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy — primary management
Participants must have received at least one prior platinum-based chemotherapeutic regimen for primary management of disease.
Cannot have received: weekly paclitaxel in the recurrent setting (paclitaxel)
Exception: Prior dose-dense paclitaxel as part of the initial treatment at diagnosis is allowed.
Prior treatment with weekly paclitaxel in the recurrent setting. Prior dose-dense paclitaxel as part of the initial treatment at diagnosis is allowed.
Cannot have received: BCL-XL inhibitor (navitoclax)
Prior treatment with any BCL-XL inhibitor, such as navitoclax.
Cannot have received: investigational agent
Participants who are receiving any other investigational agents for this condition or received an investigational agent within 5 half-lives of the agent or 4 weeks, whichever is shorter.
Lab requirements
Blood counts
absolute neutrophil count ≥1000/mcL; platelets ≥100,000/mcL; hemoglobin ≥8 g/dL; criteria must be met in the absence of platelet transfusion within 3 days prior to screening, without G-CSF products for two weeks and romiplostim for four weeks prior to screening
Kidney function
eGFR ≥60 mL/min (calculated using CKD-EPI creatinine equation or other formula)
Liver function
total bilirubin ≤ 1.5x institutional ULN (≤ 4.0x ULN in Gilbert's disease; ≤ 5.0x ULN in documented hepatic involvement); AST(SGOT)/ALT(SGPT) ≤3x institutional ULN (≤ 5.0x ULN in documented hepatic involvement)
Cardiac function
PT/INR ≤ 1.5x institutional ULN (unless receiving anticoagulant therapy and PT/INR or aPTT is within intended therapeutic range); baseline QTc interval ≤ 470 msec using Bazett's formula; no history of Long QT Syndrome
Participants must meet the following laboratory criteria: absolute neutrophil count ≥1000/mcL; platelets ≥100,000/mcL; hemoglobin ≥8 g/dL; total bilirubin ≤ 1.5x institutional ULN; AST(SGOT)/ALT(SGPT) ≤3x institutional ULN; PT/INR ≤ 1.5x institutional ULN; Serum albumin ≥ 3.0 g/dL; eGFR ≥60 mL/min. Baseline prolongation of QTc interval (> 470 msec) using Bazett's formula or history of Long QT Syndrome [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Beth Israel Deaconess Medical Center (BIDMC) · Boston, Massachusetts
- Dana Farber Cancer Institute · Boston, Massachusetts
- Brigham and Women's Hospital · Boston, Massachusetts
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