Can a new biologic shrink brain tumors before surgery?
NCT ID NCT07788677
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This trial is testing whether giving tarlatamab before and after surgery is safe and feasible for people with recurrent high-grade glioma, an aggressive brain cancer. Participants receive tarlatamab infusions before their tumor is removed, then continue treatment after surgery. The goal is to see if this approach can help control the disease and improve outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tarlatamab, an experimental biologic given by intravenous infusion before and after surgery
- What this could lead to
- If successful, this approach could offer a new way to treat recurrent high-grade glioma, potentially improving survival and quality of life.
- What could go wrong
- This is an early-phase trial with only 10 participants, so results may not apply broadly. Tarlatamab can cause serious side effects like cytokine release syndrome and neurological toxicity.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years. 2. Ability to provide written informed consent. 3. Histologically confirmed diagnosis of DLL3 positive high-grade glioma (HGG). 4. Candidate for neurosurgical resection of HGG, either in the category of supramaximal contrast-enhancing (CE) resection (class 1), maximal CE resection (class 2), or submaximal CE resection (class 3), according to the RANO resect group classification system for extent of resection (EOR). 5. Surgery can be safely delayed for a minimum of 2 weeks following the Day 15 (D15) administration of study immunotherapy. 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 7. Adequate organ function, defined as follows: a. Hematological function: i. Absolute neutrophil count ≥ 1.5 x 109/L ii. Platelet count ≥ 100 x 109/L iii. Hemoglobin ≥ 9 g/dL (90 g/L) b. Coagulation function: i. prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 x institutional upper limit of normal (ULN) except for patients receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to study entry. c. Renal function: i. Estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation \> 30 mL/min/1.73 m2. d. Hepatic function: i. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x ULN (or \< 5 x ULN for patients with liver involvement). ii. total bilirubin (TBL) \< 1.5 x ULN (or \< 2 x ULN for patients with liver involvement), except for patients with Gilbert's disease. e. Pulmonary function i. No oxygen supplementation. f. Cardiac function i. cardiac ejection fraction \>/= 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) finding. 8. For women of childbearing potential: negative pregnancy test at screening. 9. Willingness to use highly effective contraception during treatment during treatment and for at least 60 days after the last dose of tarlatamab, Exclusion Criteria: 1. Candidate for biopsy only (class 4), according to the RANO resect group classification system for EOR. 2. Ongoing steroid treatment at a dose \>4 mg dexamethasone equivalents daily. 3. Active autoimmune disease that has required systemic treatment in the past 2 years (including disease-modifying agents, corticosteroids, or immunosuppressive drugs). Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is permitted. 4. Known history of human immunodeficiency virus (HIV) infection (HIV-1/2 antibodies). 5. Known active hepatitis B virus infection (hepatitis B surface antigen reactive). 6. Known active hepatitis C virus infection (HCV RNA qualitative positive). 7. Receipt of a live vaccine or live-attenuated vaccine within 30 days before the first dose of study treatment. 8. Prior malignancy within the past 3 years, except: except basal cell carcinoma or scaly skin, cervical carcinoma in situ adequately treated or other tumors treated curatively without recurrence for 3 or more years, 9. Pregnant or lactating women.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Universitari Vall D Hebron
Barcelona, Catalonia, 08035, Spain
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