Can a new biologic shrink brain tumors before surgery?

NCT ID NCT07788677

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Hospital Universitari Vall D Hebron

    Barcelona, Catalonia, 08035, Spain

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