Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Darell Bigner
Study ID
NCT04547777
Phase
PHASE1
Status
Recruiting
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Conditions

  • Glioma, Malignant

Eligibility Criteria

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

Interventions

  • D2C7-IT — DRUG
    D2C7-IT intratumoral infusion
  • 2141-V11 — DRUG
    2141-11 intratumoral infusion

Study Details

This is a phase 1 study of an anti-CD40 monoclonal antibody (2141-V11) in combination with D2C7-IT for patients with recurrent World Health Organization (WHO) grade III or IV malignant glioma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.

Key Dates

Start date
Jul 9, 2021
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: D2C7-IT + 2141-V11
    Single D2C7-IT intratumoral infusion (4613.2 ng/mL in 36 mL) over 72 hours followed by single 2141-V11 (3.0 mg, RP2D established prior to V5.0) infusion (5 dose levels) over 7 hours. This will be followed 2 weeks later by initiation of CPL subcutaneous injections of 2141-V11 at 2.0 mg, which will be repeated again 2 weeks later and then every 3 weeks for 1 year.
  • Experimental: D2C7-IT + 2141-V11 and Tumor Monorail Device (TMD) Placement
    Patients who meet eligibility and agree with TMD placement will have the TMD implanted approximately 14 days prior to D2C7-IT infusion. Intraoperative CT will be performed post implant to ensure device location accuracy and check for hemorrhage. Prior to catheter insertion for D2C7-IT infusion, the first tumor/fluid sampling through the TMD will occur. Repeated tumor/fluid sampling via the TMD will occur prior to every 2141-V11 perilymphatic infusion, i.e., approximately 2 weeks (+ 1 week) after D2C7-IT and then every 3 weeks for 1 year.

Primary Outcome Measure

Proportion of patients with dose-limiting toxicity (DLT) within each dose level [ Time Frame: 28 days after catheter removal ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
Daniel Landi, MD
[email protected]
919-684-5301
Stevie Threatt
[email protected]
919-684-5301

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NC

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