D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients

StatusRecruiting
PhasePhase 1/2
Started

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Record History

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  1. Eligibility criteria expanded, about 35 words
  2. Eligibility criteria expanded, about 21 wordsv8
  3. Primary completion date: Feb 2026 to Oct 31, 2026
    • Study completion date: Feb 2028 to Oct 31, 2028
    v7
  4. Eligibility criteria expanded, about 86 wordsv6
  5. Re-verified, no change to tracked fieldsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2023 to Sep 6, 2023
    • Site details revised
    v4
  2. Start date: May 2023 to Aug 2023v3
  3. Start date: Feb 2023 to May 2023v2
  1. Study First Submitted
  • 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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Glioma
1,260 trials monitored
See 93 trials at risk
Glioblastoma
714 trials monitored
See 57 trials at risk
The purpose of this research study is to determine the safety and efficacy of administering a single intracerebral (within the brain) dose of investigational compounds called D2C7-immunotoxin (IT) and 2141-V11 in residual disease (within tumor margins) after surgery, followed by later repeated injections of 2141-V11 in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adults newly diagnosed with a type of cancerous brain tumor called glioblastoma. The word "investigational" means the study drugs are still being tested in research studies and are not approved by the U.S. Food and Drug Administration (FDA).
Trial Details
NCT Number NCT05734560
Lead Sponsor Darell Bigner
Collaborators: Rockefeller University
Conditions
(from sponsor)		 Newly Diagnosed MGMT Unmethylated Glioblastoma
Related terms Glioblastoma
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov