Actively Recruiting
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
Led by Nader Sanai · Updated on 2026-03-06
15
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
Sponsors
N
Nader Sanai
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with recurrent Grade 4 glioma per 2021 WHO criteria or brain metastasis needing surgical resection with well-controlled systemic disease
- Have available archival or biopsy brain tumor tissue
- Have measurable disease with at least one contrast-enhancing lesion of 1 cm or larger preoperatively
- Age 18 years or older at time of consent
- Performance status of 2 or less on the ECOG scale
- Adequate bone marrow, liver, kidney, metabolic, and coagulation function per specified laboratory values
- For females of childbearing potential: negative pregnancy test before treatment and agree to use effective contraception during and for 8 months after treatment, no breastfeeding, and no egg donation
- For females not of childbearing potential: no longer able to have children due to menopause or surgery
- For males: agree to refrain from sperm donation and use contraception or abstain from heterosexual intercourse during and for 5 months after treatment
- Agree to follow lifestyle considerations during the study
- Able and willing to comply with study visits, treatments, and tests
- Understand and voluntarily sign informed consent
You will not qualify if you...
- Evidence of leptomeningeal metastasis or spinal cord compression
- Unable to undergo brain MRI with contrast
- Active systemic bacterial, fungal, or viral infection needing treatment or fever above 38.5°C at treatment start
- Serious infections within 4 weeks before treatment initiation
- Severe psychiatric or uncontrolled medical conditions posing safety risks or affecting compliance
- Unresolved toxicities greater than Grade 1 from prior therapy (with some exceptions)
- Prior treatment with certain B7-H3 targeted agents, investigational drugs within 4 weeks, or chemotherapy, monoclonal antibodies, immunosuppressives within specified timeframes
- Use of strong/moderate inhibitors of certain enzymes within 7 days before treatment
- Blood transfusions or colony-stimulating factors within 14 days prior to enrollment
- Major surgery within 4 weeks before treatment posing safety risks
- Significant bleeding within 1 month before treatment
- Allergies or severe hypersensitivity to the study drug or its components
- History of bone marrow or solid organ transplant
- Current or history of interstitial lung disease or pneumonitis requiring high-dose steroids
- Moderate to severe lung disease
- Serious or uncontrolled cardiovascular disorders or abnormal heart test results
- Active infectious diseases requiring treatment or known HIV
- Positive hepatitis B or C tests unless resolved
- Cirrhosis or unstable liver/biliary disease
- Autoimmune disease requiring systemic treatment in past 2 years
- Active significant kidney conditions
- Unable to adhere to study schedule and procedures
- Vaccination or hypersensitivity within 4 weeks before treatment
- Received live vaccine within 30 days before treatment
- Pregnant or breastfeeding
- Blood donation over 500 mL within 1 month before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Actively Recruiting
Research Team
P
Phase 0 Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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