D2C7-IT With Atezolizumab for Recurrent Gliomas

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Darell Bigner
Study ID
NCT04160494
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Malignant Glioma

Eligibility Criteria

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

Interventions

  • D2C7-IT (6920 ng/mL via convection-enhanced delivery) — DRUG
    dual-specific mAB
  • Atezolizumab (1200 mg every three weeks) — DRUG
    programmed cell death ligand 1 (PD-L1) blocking antibody
  • D2C7-IT (4613.2 ng/mL via convection-enhanced delivery) — DRUG
    dual-specific mAB

Study Details

This is a phase 1 study of atezolizumab in combination with D2C7-IT, a dual-specific monoclonal antibody (mAB) with a high affinity for both EGFRwt- and EGFRvIII-expressing cells, in patients with recurrent World Health Organization (WHO) grade IV malignant glioma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.

Key Dates

Start date
Feb 25, 2020
Status verified
Jun 2026
Primary completion
Jun 28, 2024
Completion
Dec 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: D2C7-IT (6920 ng/mL) + Atezolizumab
    Single D2C7-IT convection-enhanced delivery (CED) infusion (6920 ng/mL) plus atezolizumab (1200 mg) intravenous (IV) infusions every three weeks for up to two years
  • Experimental: D2C7-IT (4613.2 ng/mL) + Atezolizumab
    Single D2C7-IT convection-enhanced delivery (CED) infusion (4613.2 ng/mL) plus atezolizumab (1200 mg) intravenous (IV) infusions every three weeks for up to two years

Primary Outcome Measure

Proportion of patients with an unacceptable adverse event [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NC

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