D2C7-IT With Atezolizumab for Recurrent Gliomas

NCT04160494 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-05-11

No results posted yet for this study

Summary

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.

Conditions

  • Malignant Glioma

Interventions

DRUG

D2C7-IT (6920 ng/mL via convection-enhanced delivery)

dual-specific mAB

DRUG

Atezolizumab (1200 mg every three weeks)

programmed cell death ligand 1 (PD-L1) blocking antibody

DRUG

D2C7-IT (4613.2 ng/mL via convection-enhanced delivery)

dual-specific mAB

Sponsors & Collaborators

  • Istari Oncology, Inc.

    collaborator INDUSTRY
  • National Cancer Institute (NCI)

    collaborator NIH
  • Genentech, Inc.

    collaborator INDUSTRY
  • Darell Bigner

    lead OTHER

Principal Investigators

  • Daniel Landi, MD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-25
Primary Completion
2024-06-28
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04160494 on ClinicalTrials.gov