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A Phase I/II Study of IVONESCIMAB in Recurrent Glioblastoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

A Phase I/II Study of IVONESCIMAB in Recurrent Glioblastoma

NCT06672575•M.D. Anderson Cancer Center

Summary

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.

Detailed Description

Primary Objectives: * To determine the safety and tolerability of ivonescimab in adult patients with recurrent glioblastoma * To determine the median progression free survival and progression free survival rate at 6 months of ivonescimab in adult patients with recurrent glioblastoma

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years
•2. Karnofsky Performance Status (KPS) of 60 or greater
•3. Recurrent supratentorial Glioblastoma that has progressed following standard therapy; patients must have previously been treated with radiation with or without temozolomide.
•1. Patients will be eligible at first or second recurrence.
•2. Patients must be greater than 12 weeks from completion of initial chemoradiation at the time of progression, with the exception that patients with biopsy-confirmed recurrent disease prior to this time window can be enrolled.
•4. Diagnosis of Glioblastoma IDH-wildtype, WHO Grade 4 consistent with WHO CNS 2021 criteria. This will include patients with a diagnosis of molecular glioblastoma.
•5. Measurable or evaluable disease per RANO criteria
•6. A baseline MRI Brain no more than 14 days prior to study enrollment
•7. Adequate Organ Function, with screening labs performed within 14 days of treatment initiation:
•a. Hematology (no blood transfusions or growth factor therapy used within 7 days of the screening CBC): i. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L ii. Platelet count ≥ 100 × 109/L iii. Hemoglobin ≥ 9.0 g/dL b. Kidneys: i. Creatinine clearance\* (CrCL) ≥ 50 mL/min using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥50 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (adjustment by BSA is not required for eGFR)
+14 more criteria

Exclusion Criteria

•1. Major surgical procedures or serious trauma, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator).
•Minor local procedures (excluding central venous catheterization and port implantation).
•2. Currently pregnant or breastfeeding.
•3. History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms, including but not limited to:
•a. Significant intracranial hemorrhage
•1. Note: Patients with clinically asymptomatic presence of hemosiderin, resolving postoperative changes or punctate intratumoral hemorrhage are permitted
•2. Gastrointestinal bleeding
•b. Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots) Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed. c. Nasal bleeding /epistaxis (bloody nasal discharge is allowed) d. Need for therapeutic anticoagulant therapy Note: Prophylactic anticoagulation for DVT/PE or to maintain venous patency is allowed.
•4. Current hypertension with systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy
•5. Is receiving dexamethasone \>2mg daily, or the corticosteroid equivalent thereof.
+12 more criteria

Locations (2)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

January 30, 2025

Primary Completion Date

January 31, 2028

Completion Date

January 31, 2030

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Glioblastoma

Interventions

Ivonescimab

DRUG

Contacts

Evguenia Gachimova, MD

CONTACT

832-266-3519 Neuro-OncologyResearchTrials@mdanderson.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase I/II Study of IVONESCIMAB in Recurrent Glioblastoma

Inclusion Criteria

Exclusion Criteria

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

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