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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 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.

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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.

Conditions Studied

Glioblastoma

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

FieldValue
Enrollment Target 46 participants
Start Date 2021-04-21
Est. Completion 2026-12-31
Phase Early Phase 1

Sponsor

Yale University

1,492 total trials

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What the Registry Record Tells You About NCT04656535

The ClinicalTrials.gov registry entry for NCT04656535 describes a study currently listed as active not recruiting, categorized as Early Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (58% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.