DT2216 + Paclitaxel in Platinum-Resistant Ovarian Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Elizabeth Stover, MD, PhD
Study ID
NCT06964009
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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)

Key Dates

Start date
Sep 22, 2025
Status verified
Apr 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DT2216 + Paclitaxel
    Dose de-escalation and escalation for the DT2216 and Pacllitaxel combination will be guided using a Bayesian Optimal Interval (BOIN) design. Enrolled participants will complete: * Baseline visit * Imaging every 2 cycles * ECG Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycle 2. * Research blood sample Days 1, 2, 4, 8, 15, 16, 18 and 22 of Cycle 1 and Day 1 of every cycle. * Cycle 1 (28 day cycles): * Days 1, 4, 8, 11, 15, 18, 22, and 25: Predetermined dose of DT2216 1x daily * Days 1, 8, 15: Predetermined dose of Paclitaxel 1x daily * Cycle 2 through end of treatment (28 day cycles): * Days 1, 4, 8, 11, 15, 18, 22, 25: Predetermined dose of DT2216 1x daily * Days 1, 8, 15: Predetermined dose of Paclitaxel 1x daily * End of treatment visit with imaging * 30 day follow up visit

Primary Outcome Measure

DT2216 Maximum Tolerated Dose (MTD) [ Time Frame: Assessed on Day 1, 4, 8, 11, 15, 18, 22 and 25 on cycle 1 and up to start of cycle 2; cycle 1 duration=28 days plus 14 days maximum until start of cycle 2, for a maximum time frame of 42 days. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical Center (BIDMC)BostonMassachusetts02115
Meghan Shea, MD
Meghan Shea, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02215
Elizabeth Stover, MD, PhD
[email protected]
617-632-6866
Elizabeth Stover, MD, PhD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02115
Elizabeth Stover, MD, PhD
[email protected]
617-632-6866
Elizabeth Stover, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Beth Israel Deaconess Medical Center (BIDMC)· Boston, MABrigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

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