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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Nader Sanai
Study ID
NCT07268053
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Brain Metastasases
  • Glioblastoma (GBM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Risvutatug rezetecan — DRUG
    Risvutatug rezetecan will be administered intravenously.

Study Details

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.

Key Dates

Start date
Feb 11, 2026
Status verified
Nov 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: rGBM and Brain Mets
    Group A will include participants with recurrent WHO Grade 4 glioma (rGBM) and group B will include participants with brain metastases (brain mets)

Primary Outcome Measure

Phase 0: Total, Cleaved, and Unbound GSK5757810 Payload Concentration in Tumor Tissue [ Time Frame: Intraoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Joseph's Hospital and Medical CenterPhoenixArizona85013
Phase 0 Navigator
[email protected]
602-406-8605
Nader Sanai, MD (PRINCIPAL_INVESTIGATOR)

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By research site
St. Joseph's Hospital and Medical Center· Phoenix, AZ

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