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NCT07268053 · ClinicalTrials.gov registry record · Early Phase 1
A Phase 0/1 Clinical Trial With an Expansion Phase of GSK5764227, a B7-H3-Targeted Antibody-Drug Conjugate (ADC), in Patients With Recurrent Grade 4 Glioma and Patients With Brain Metastases
A Early Phase 1 study of Glioblastoma (GBM) and Brain Metastasases, sponsored by Nader Sanai.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT07268053 is a Early Phase 1 study of Glioblastoma (GBM) and Brain Metastasases that is actively recruiting participants, run by Nader Sanai. The registered enrollment target is 15 participants, below the 85-participant average among 7 other Glioblastoma (GBM) trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07268053, a Early Phase 1 study of Glioblastoma (GBM) and Brain Metastasases, is actively recruiting participants, sponsored by Nader Sanai.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be an open-label Phase 0/1 study that will enroll approximately 15 participants, 9 participants with recurrent WHO Grade 4 glioma (rGBM) and 6 participants with brain metastases, who will receive the investigational drug risvutatug rezetecan (GSK5764227), a B7-H3-targeted antibody-drug conjugate (ADC) with the GSK5757810 payload. The trial will consist of a Phase 0 component (subdivided into Arms A and B) and an Expansion Phase 1 component. Participants with tumors demonstrating a positive pharmacokinetic (PK) response in the Phase 0 component will be eligible to enroll in the Expansion Phase to receive therapeutic dosing of risvutatug rezetecan.
Conditions Studied
Interventions
- DRUG Risvutatug rezetecan
Study Locations (1)
Arizona
- St. Joseph's Hospital and Medical Center - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2026-02-11 |
| Est. Completion | 2029-07 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07268053
The ClinicalTrials.gov registry entry for NCT07268053 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 85-participant average among 7 other Glioblastoma (GBM) trials with a reported enrollment target (82% lower). The listed sponsor is Nader Sanai, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Glioblastoma (GBM) appearing as the primary indexed condition, and to 1 intervention - of which Risvutatug rezetecan is the first listed.
NCT07268053 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT07268053 about?
NCT07268053 is a clinical study titled "A Phase 0/1 Clinical Trial With an Expansion Phase of GSK5764227, a B7-H3-Targeted Antibody-Drug Conjugate (ADC), in Patients With Recurrent Grade 4 Glioma and Patients With Brain Metastases". This will be an open-label Phase 0/1 study that will enroll approximately 15 participants, 9 participants with recurrent WHO Grade 4 glioma (rGBM) and 6 participants with brain metastases, who will receive the investigational drug risvutatug rezetecan (GSK5764227), a B7-H3-targeted antibody-drug con...
What is the current status of trial NCT07268053?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2026-02-11. Estimated completion is 2029-07.
What conditions does trial NCT07268053 study?
This clinical trial studies the following conditions: Glioblastoma (GBM), Brain Metastasases.
What interventions are being tested in trial NCT07268053?
The interventions under investigation include: Risvutatug rezetecan (DRUG).
Who is sponsoring clinical trial NCT07268053?
This trial is sponsored by Nader Sanai, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07268053 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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