GlioblastomaPhase 1/2NCT06672575
A Phase I/II Study of IVONESCIMAB in Recurrent Glioblastoma
A Phase 1/2 study testing Ivonescimab in people with Glioblastoma, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Ivonescimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jan 2025to 31 Jan 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Karnofsky Performance Status (KPS) of 60 or greater
- Recurrent supratentorial Glioblastoma that has progressed following standard therapy; patients must have previously been treated with radiation with or without temozolomide.
- Patients will be eligible at first or second recurrence.
- 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.
- Diagnosis of Glioblastoma IDH-wildtype, WHO Grade 4 consistent with WHO CNS 2021 criteria. This will include patients with a diagnosis of molecular glioblastoma.
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- Measurable or evaluable disease per RANO criteria
- A baseline MRI Brain no more than 14 days prior to study enrollment
- Adequate Organ Function, with screening labs performed within 14 days of treatment initiation:
- 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)
- CrCL or eGFR can be determined using the calculator from the National Kidney Foundation website (www.kidney.org).
- Urine protein < 2+ or 24-hour urine protein quantification < 1.0 g or Urine protein/Creatinine ratio ≤ 1mg/mg (≤ 113.2mg/mmol) c. Liver: i. Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); For patients with confirmed/suspected Gilbert syndrome, TBIL ≤3 × ULN ii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN d. Coagulation: prothrombin time (PT) or international normalized ratio (INR)
- 1.5 × ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy or prophylactic coagulation)
- Female patients of childbearing age must have negative serum pregnancy test results before randomization or per region-specific guidance documented in the informed consent and a negative urine pregnancy test on the day of first dose prior to dosing.
- Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of the ivonescimab.
- Male patients of childbearing potential having sex with a female partner of childbearing potential must agree to use an effective method of contraception from the beginning of screening until Day 90 after the last dose of ivonescimab.
- Ability to understand and willingness to sign informed consent form prior to the initiation of study and any study procedures.
- Participants with cognitive impairment may be enrolled. The formal consent for such participants will be obtained from their legally authorized representative. However, participants will be informed about the research to the maximum extent compatible with their understanding. Assent will be obtained from such participants who will sign and date the consent form if capable.
- Non-English speakers are allowed to enroll provided consent and all visits will be conducted with a medical interpreter.
Who cannot join
- 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).
- Currently pregnant or breastfeeding.
- History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms, including but not limited to:
- Significant intracranial hemorrhage
- Note: Patients with clinically asymptomatic presence of hemosiderin, resolving postoperative changes or punctate intratumoral hemorrhage are permitted
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- Gastrointestinal bleeding
- 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.
- Current hypertension with systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy
- Is receiving dexamethasone >2mg daily, or the corticosteroid equivalent thereof.
- History of major diseases, specifically:
- Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association [NYHA] classification ≥ grade 2) or vascular disease (eg, aortic aneurysm at risk of rupture), or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)
- History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding
- History of arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy
- Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks beforerandomization
- History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection)
- History of other malignancy diagnosed or requiring treatment within the past 3 years prior to enrolment, with the exception of those with negligible expected risk of metastasis or death (including adequately treated non- melanoma skin cancer or cervical carcinoma in situ).
- History of prior treatment of GB with anti-VEGF and/or anti-PD-1/PDL-1 agents, including monotherapy with either category or combinations thereof.
- Has received prior interstitial brachytherapy, interstitial thermal therapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced deliver. Prior treatment with Gliadel ® wafers will be excluded. Concurrent use of devices such as Tumor Treating Fields is not permitted.
- Has known leptomeningeal disease, gliomatosis cerebri, extracranial disease, or multicentric disease (regionally multifocal enhancing disease with continguous T2/FLAIR is permitted to be enrolled)
- Uncontrolled seizures after best medical therapy or other neurological conditions including clinically significant autoimmune neurological disorders which can increase risk for adverse effects or confound assessment of study outcomes as determined by the treating physician and PI
- History of clinically significant autoimmune disease including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, granulomatosis with polyangiitis, Sjogren's syndrome, GuillainBarré syndrome, multiple sclerosis, vasculitis or glomerulonephritis
- Patients with a history of autoimmune hypothyroidism may be eligible if on a stable dose of thyroid replacement hormone
- Patients with controlled Type 1 diabetes mellitus may be eligible if on a stable insulin regimen
- Patients with dermatologic disorders (e.g., eczema) may be eligible if well controlled at baseline and not requiring systemic treatment or other treatments beyond low potency topical steroids
- Has contraindication for undergoing MRI scans or receiving MRI contrast.
- History of stroke or TIA within 6 months prior to study enrolment.
- Imaging during the screening period shows that the patient has:
- Radiologically documented evidence of major blood vessel invasion or encasement by cancer
- Radiographic evidence of intratumor cavitation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Evguenia Gachimova, 832-266-3519, Neuro-OncologyResearchTrials@mdanderson.org
Anuj D Patel, MD
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the 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
- Conditions
- Glioblastoma
- Being tested
- Ivonescimab
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvonescimabDrug
Participante will recived an infusion by vein
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Ivonescimab | Experimental | Participants will be enrolled in either Phase 1 or Phase 2 depending on when they join the study. Receives: Drug: Ivonescimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start30 Jan 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Summit Therapeutics
- Responsible party
- Sponsor
- Investigators
- Anuj D Patel, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672575
- Sponsor's protocol ID
- 2024-1277
- Other IDs
- NCI-2024-09210
- Status last verified
- Jul 2026
- First submitted
- 1 Nov 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of IVONESCIMAB in Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT06672575
- Acronym / sponsor ID
- 2024-1277
- Conditions
- Glioblastoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Summit Therapeutics
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Ivonescimab | Experimental | Drug: IvonescimabParticipants will be enrolled in either Phase 1 or Phase 2 depending on when they join the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥18 years
- Karnofsky Performance Status (KPS) of 60 or greater
- Recurrent supratentorial Glioblastoma that has progressed following standard therapy; patients must have previously been treated with radiation with or without temozolomide.
- Diagnosis of Glioblastoma IDH-wildtype, WHO Grade 4 consistent with WHO CNS 2021 criteria. This will include patients with a diagnosis of molecular glioblastoma.
- Measurable or evaluable disease per RANO criteria
Key exclusion criteria (30 listed)
- 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).
- Currently pregnant or breastfeeding.
- History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms, including but not limited to:
- Current hypertension with systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IvonescimabParticipante will recived an infusion by vein | Drug | Treatment with Ivonescimab |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anuj D Patel, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ivonescimab in people with Glioblastoma, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evguenia Gachimova, MD (832-266-3519, Neuro-OncologyResearchTrials@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.