Actively Recruiting
A Phase I/II Study of Ivonescimab in Adults with Recurrent Glioblastoma
Led by M.D. Anderson Cancer Center · Updated on 2026-06-05
45
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
S
Summit Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating ivonescimab, a drug given by vein infusion, in adults with recurrent glioblastoma, a type of brain cancer that has returned after standard treatment. The study is conducted in two parts: Phase 1 aims to find the highest dose of ivonescimab that patients can tolerate and to determine the recommended dose for Phase 2. Phase 2 will then assess whether this dose can help control the disease. The study is sponsored by M.D. Anderson Cancer Center and includes adult patients aged 18 and older. Participants receive ivonescimab intravenously during the study. Depending on when they join, they will be enrolled in either Phase 1 or Phase 2. Phase 1 focuses on safety and tolerability, while Phase 2 evaluates the drug's impact on disease control. The study does not use a placebo or masking. Treatments and doses are adjusted based on the study phase and ongoing assessments. Throughout the study, participants will be closely monitored for safety and any side effects, with evaluations continuing for about one year. Assessments include brain MRI scans done before starting treatment and regular lab tests to check organ function. Researchers will measure how long participants live without the disease worsening and any adverse events experienced. Participants must be able to provide informed consent, and efforts are made to include those with cognitive impairments or who speak languages other than English through interpreters.
CONDITIONS
Brief Title
A Phase I/II Study of IVONESCIMAB in Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Karnofsky Performance Status (KPS) of 60 or greater
- Recurrent supratentorial glioblastoma that has progressed after standard therapy, including prior radiation with or without temozolomide
- Eligible at first or second recurrence
- More than 12 weeks since completion of initial chemoradiation unless biopsy-confirmed recurrence earlier
- Diagnosis of Glioblastoma IDH-wildtype, WHO Grade 4 (including molecular glioblastoma)
- Measurable or evaluable disease per RANO criteria
- Baseline brain MRI within 14 days before enrollment
- Adequate organ function based on recent lab tests
- Negative pregnancy tests for females of childbearing potential
- Use of effective contraception for females and males of childbearing potential
- Ability to understand and sign informed consent; cognitive impairment allowed with legally authorized representative consent
- Non-English speakers allowed with medical interpreter
You will not qualify if you...
- Major surgery or serious trauma within 4 weeks after first dose
- Currently pregnant or breastfeeding
- History of significant bleeding disorders or clinically significant bleeding symptoms
- Current hypertension not controlled below systolic 150 mmHg or diastolic 100 mmHg after treatment
- Use of dexamethasone greater than 2 mg daily or equivalent corticosteroids
- History of major heart disease or vascular conditions affecting safety evaluation
- History of severe gastrointestinal diseases or bleeding
- History of serious thromboembolic events or cerebrovascular conditions
- Recent acute exacerbation of COPD
- History of gastrointestinal tract perforation, fistula, obstruction, or extensive bowel surgery
- Other malignancies within past 3 years except certain low-risk skin or cervical cancers
- Prior treatment with anti-VEGF or anti-PD-1/PDL-1 agents
- Prior local therapies such as brachytherapy or implanted chemotherapy
- Known leptomeningeal, extracranial, or multicentric disease
- Uncontrolled seizures or significant autoimmune neurological disorders
- Clinically significant autoimmune diseases except stable hypothyroidism, controlled Type 1 diabetes, or controlled dermatologic disorders
- Contraindications to MRI or MRI contrast
- Stroke or transient ischemic attack within 6 months before enrollment
- Imaging showing major blood vessel invasion or intratumor cavitation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Through study completion; an average of 1 year
Participants receive ivonescimab through vein infusion as treatment for recurrent glioblastoma.
Regular visits for infusions and monitoring during treatment
Trial Site Locations
Total: 2 locations
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
2
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Evguenia Gachimova, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here