Actively Recruiting
A Phase I/II Study of IVONESCIMAB in Recurrent Glioblastoma
Led by M.D. Anderson Cancer Center · Updated on 2026-02-27
45
Participants Needed
2
Research Sites
261 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
The goal of Phase 1 of this clinical research study is to find the highest tolerable dose and the recommended Phase 2 dose of ivonescimab that can be given to patients who have recurrent glioblastoma. The goal of Phase 2 of this clinical research study is to learn if the recommended Phase 2 dose of ivonescimab found in Phase 1 can help to control the disease.
CONDITIONS
Official 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 progressed after standard therapy including radiation with or without temozolomide
- Eligible at first or second recurrence
- More than 12 weeks since completion of initial chemoradiation at progression, except biopsy-confirmed recurrence earlier
- Diagnosis of glioblastoma IDH-wildtype, WHO Grade 4 per WHO CNS 2021 criteria
- Measurable or evaluable disease per RANO criteria
- Baseline brain MRI within 14 days prior to enrollment
- Adequate organ function as shown by recent lab tests
- Negative pregnancy tests for females of childbearing potential before treatment
- Use of effective contraception for females and males of childbearing potential during and 120 days after last dose
- Ability to understand and sign informed consent; legally authorized representative consent allowed for cognitive impairment
- Non-English speakers allowed with medical interpreter
You will not qualify if you...
- Major surgery or serious trauma within 4 weeks before first dose
- Currently pregnant or breastfeeding
- History of bleeding disorders or significant bleeding symptoms
- Current uncontrolled hypertension (systolic 6 150 mmHg or diastolic 6 100 mmHg)
- Receiving dexamethasone greater than 2 mg daily or equivalent corticosteroids
- History of major heart disease, severe ulcers, significant thromboembolic events, acute COPD exacerbation within 4 weeks
- History of gastrointestinal perforation, obstruction, or extensive bowel resection
- Other malignancy requiring treatment within past 3 years except certain skin or cervical cancers
- Prior treatment with anti-VEGF or anti-PD-1/PDL-1 agents
- Prior local therapies like interstitial brachytherapy or Gliadel wafers
- Known leptomeningeal disease, gliomatosis cerebri, extracranial or multicentric disease
- Uncontrolled seizures or neurological autoimmune disorders
- History of clinically significant autoimmune disease with some exceptions
- Contraindication to MRI or MRI contrast
- History of stroke or transient ischemic attack within 6 months
- Imaging showing major blood vessel invasion or intratumor cavitation
AI-Screening
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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
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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