D2C7-IT With Atezolizumab for Recurrent Gliomas

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed Show 5 more changesShow less
    • Final enrollment: 14 participants (planned 18)
    • Study completion date changed from estimate of Dec 2027 to Jun 11, 2026
    • Interventions: Atezolizumab (1200 mg every three weeks) (Drug), D2C7-IT (4613.2 ng/mL via convection-enhanced delivery) (Drug), D2C7-IT (6920 ng/mL via… to Atezolizumab (1200 mg every three weeks) (Drug), D2C7-IT (4613.2 ng/mL via convection-enhanced delivery) (Drug), D2C7-IT (6920 ng/mL via…
    • Eligibility criteria expanded, about 38 words
    • Study description revised
  2. 2 versions Re-verified since Jun 2, 2026, no change to tracked fieldsv19-v20
  3. Primary completion date changed from estimate of Dec 2025 to Jun 28, 2024v18
  4. Primary completion date: Dec 2024 to Dec 2025v17
  5. Lead sponsor: Annick Desjardins, MD to Darell Bignerv16
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  1. Lead sponsor: Darell Bigner to Annick Desjardins, MD
    • Primary completion date: Dec 2023 to Dec 2024
    • Start date: Mar 20, 2020 to Feb 25, 2020
    v15
  2. Re-verified, no change to tracked fieldsv14
  3. Primary completion date: Jan 2023 to Dec 2023
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jan 2027 to Dec 2027
    • Site details revised
    v13
  4. Primary completion date: Jan 2022 to Jan 2023
    • Study completion date: Jan 2026 to Jan 2027
    v12
  5. Trial status: Suspended to Recruiting
    • Site details revised
    v11
  6. Sponsor's reason: The Principal Investigator (PI) for this study is changing. The study will re-open once the new PI is approved. to Database changev10
  7. Trial status: Recruiting to Suspended Sponsor's reason: The Principal Investigator (PI) for this study is changing. The study will re-open once the new PI is approved.
    • Site details revised
    v9
  8. Primary completion date: Jan 2021 to Jan 2022v8 Show 4 more changesShow less
    • Study completion date: Jan 2025 to Jan 2026
    • Interventions: Atezolizumab (1200 mg every three weeks) (Drug), D2C7-IT (6920 ng/mL via convection-enhanced delivery) (Drug) to Atezolizumab (1200 mg every three weeks) (Drug), D2C7-IT (4613.2 ng/mL via convection-enhanced delivery) (Drug), D2C7-IT (6920 ng/mL via…
    • Study description expanded, about 29 words
    • Study arms: 1 to 2
  9. Eligibility criteria expanded, about 139 words
    • Study description shortened, about 69 words
    v7
  10. Start date changed from estimate of Mar 31, 2020 to Mar 20, 2020v6
  11. Start date: Feb 25, 2020 to Mar 31, 2020v5
  12. Lead sponsor: Darell D. Bigner, MD, PhD to Darell Bigner
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 2020 to Feb 25, 2020
    • Site details revised
    v4
  13. Start date: Dec 2019 to Feb 2020v3
  14. Collaborators: 2 to 3v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Darell Bigner
6 trials monitored
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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.
Trial Details
NCT Number NCT04160494
Lead Sponsor Darell Bigner
Collaborators: Istari Oncology, Inc., National Cancer Institute (NCI), Genentech, Inc.
Conditions
(from sponsor)		 Malignant Glioma
Related terms Glioblastoma, Glioma
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov