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NCT04656535 · ClinicalTrials.gov registry record · Early Phase 1
AB154 Combined With AB122 for Recurrent Glioblastoma
A Early Phase 1 study of Glioblastoma, sponsored by Yale University.
- Active
- Registry status
- Early Phase 1
- Development phase
- 46
- Enrollment target
- 3
- Study locations
NCT04656535: Active Early Phase 1 study of Glioblastoma, sponsored by Yale University.
NCT04656535 is a Early Phase 1 study of Glioblastoma that is active but no longer recruiting, run by Yale University. The registered enrollment target is 46 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (58% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04656535, a Early Phase 1 study of Glioblastoma, is active but no longer recruiting, sponsored by Yale University.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 46 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a phase 0/I exploratory study. Patients at first or second recurrence of glioblastoma will be enrolled. The study will be divided into two cohorts: Cohort A (safety cohort) and Cohort B (surgical patient cohort). Cohort A: Eligible patients will be sequentially enrolled to receive intravenous domvanalimab combined with zimberelimab (N=6). Domvanalimab will be given at a dose of 10 mg/kg and zimberelimab will be given at a dose of 240 mg (flat). The dosing was determined in a separate study in solid tumors; this cohort will confirm the safety of the dosing schedule in patients with brain tumors. Cohort B: Expansion surgical cohort. The purpose of cohort B is to provide an additional safety evaluation of domvanalimab + zimberelimab as well as tissue and blood for exploratory ancillary studies investigating the effects of domvanalimab + zimberelimab in the tumor and tumor microenvironment. A total of 46 patients will be enrolled in this cohort.
Primary Outcome
Adverse events will be listed individually by patient and treatment group. The number of patients experiencing each adverse event will be summarized by organ and grade. The number and percentage of patients with adverse events in the different categories will be summarized by treatment group.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Zimberelimab
- DRUG Domvanalimab
Study Locations (3)
California
- University of California San Francisco - San Francisco
Connecticut
- Yale University - New Haven
Massachusetts
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2021-04-21 |
| Est. Completion | 2026-12-31 |
| Phase | Early Phase 1 |
What the registry record for NCT04656535 still lists
NCT04656535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04656535 reports a single indexed study location in California, Connecticut, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04656535 about?
NCT04656535 is a clinical study titled "AB154 Combined With AB122 for Recurrent Glioblastoma". This is a phase 0/I exploratory study. Patients at first or second recurrence of glioblastoma will be enrolled. The study will be divided into two cohorts: Cohort A (safety cohort) and Cohort B (surgical patient cohort). Cohort A: Eligible patients will be sequentially enrolled to receive intraveno...
What is the current status of trial NCT04656535?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 46 participants. The study started on 2021-04-21. Estimated completion is 2026-12-31.
What conditions does trial NCT04656535 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT04656535?
The interventions under investigation include: Placebo (DRUG), Zimberelimab (DRUG), Domvanalimab (DRUG).
Who is sponsoring clinical trial NCT04656535?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04656535 being conducted?
This trial has 3 study locations across California, Connecticut, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04656535's enrollment target sits among peer trials
46 96th of 199 higher than 104 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
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