A Phase 1 interventional study of Tarlatamab in High-Grade Glioma (HGG), sponsored by Vall d'Hebron Institute of Oncology. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Vall d'Hebron Institute of Oncology · Phase 1, Interventional, and Treatment
Among 46 studies in Glioma with a site in Spain — 14 open to participants now, 21 under way, 2 of them phase 3. Glioma · Spain.
Among the 46 studies in Glioma with a site in Spain, this one is the 36th largest by planned enrollment of the 38 interventional ones that give a count, is the only one that started in 2027, is one of 8 in phase 1, reaches primary completion later than 17 of the 20 other live ones, and was the 43rd registered.
1,452 studies on the registry are indexed under Glioma; 349 are open to participants now.
Browse Glioma studies →14 of the 46 studies in Glioma with a site in Spain are open now. Recruiting first, the newest first:
Fundacion Clinic per a la Recerca Biomédica · Sites in Spain
Ages 18+
Clinica Universidad de Navarra, Universidad de Navarra · Sites in Spain, Netherlands
Ages 1–25
Fundación de investigación HM · Sites in Spain
Ages 3+
Boehringer Ingelheim · Sites in Spain, United States, Austria and 3 more countries
Ages 18+
European Organisation for Research and Treatment of Cancer - EORTC · Sites in Spain, Austria, Belgium and 9 more countries
Ages 18+
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 267 Glioma studies recruiting now, 164 (61%) set no upper age limit and 57 (21%) stop at 75 or younger; 63 take children under 18; 15 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
46 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 16 · Phase 2 21 · Phase 3 4 · Phase 4 2
First in 2005; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 10 is below the median of 32 across 1,075 interventional studies indexed under Glioma.
Median enrollment 60 across the 38 interventional studies, 110 across the 8 observational. Of the 24 that completed or were terminated, 11 (46%) have results posted.
This tab as a report to print or save as PDF → With an account.
30 of 46 have an industry lead sponsor. The 10 most frequent:
Vall d'Hebron Institute of Oncology is the lead sponsor of 21 studies on the registry; 13 are open to participants now.
Vall d'Hebron Institute of Oncology has 1 study filed under Glioma — fewer than ten, so there is no comparison to draw.
4 of the studies in Glioma with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06413706Eli Lilly and CompanyA Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy | 2027-02 |
| NCT07813377Fundacion Clinic per a la Recerca BiomédicaUsefulness of Thromboelastography as a Predictor of Prognosis in Patients Undergoing Surgery for Glial Tumors and of the Risk of Postoperative Thromboembolic Disease (GliTEM) | 2027-05-30 |
| NCT02650401Hoffmann-La RocheStudy Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options | 2027-06-30 |
| NCT05916313Boehringer IngelheimA Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With a Tumour in the Brain That is Positive for DLL3 | 2027-08-09 |
Add all 4 to your calendar (.ics) → With an account.
Among the 46 studies in Glioma with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a single-arm, window-of-opportunity clinical study evaluating tarlatamab administered before and after surgery in adult participants with surgically resectable recurrent DLL3-positive high-grade glioma. The study is designed to assess the feasibility and safety of neoadjuvant tarlatamab treatment prior to planned tumor resection, as well as the safety and tolerability of postoperative adjuvant tarlatamab.
Eligible participants will have histologically confirmed recurrent high-grade glioma with DLL3-positive tumor expression and will be candidates for neurosurgical resection in whom surgery can be safely delayed to allow neoadjuvant treatment. Participants will receive tarlatamab intravenously using a step-up dosing regimen during the neoadjuvant phase, followed by planned surgical resection after a washout period. After recovery from surgery, participants will restart tarlatamab with step-up dosing and continue adjuvant treatment every 2 weeks for up to 6 cycles.
The primary objective is to evaluate the feasibility and safety of neoadjuvant tarlatamab, including the number of participants able to complete the dose-limiting toxicity evaluation period and undergo planned surgery without experiencing a dose-limiting toxicity. Safety assessments will include adverse events graded according to CTCAE v5.0, as well as cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome graded according to ASTCT criteria.
Secondary objectives include assessment of antitumor activity using RANO and iRANO criteria, progression-free survival, 12-month overall survival, quality of life using EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaires, and the incidence, severity, and type of treatment-emergent adverse events during the adjuvant treatment period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate organ function, defined as follows:
a. Hematological function: i. ≥ 1.5 x 109/L ii. count ≥ 100 x 109/L iii. ≥ 9 g/dL (90 g/L) b. Coagulation function: i. (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 x institutional (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 (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation > 30 mL/min/1.73 m2.
d. Hepatic function: i. (AST) and alanine aminotransferase (ALT) \< 3 x ULN (or \< 5 x ULN for patients with liver involvement).
ii. total (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 >/= 50%, no pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant (ECG) finding.
Exclusion Criteria:
Active disease that has required systemic treatment in the past 2 years (including disease-modifying agents, corticosteroids, or drugs).
Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is permitted.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with surgically resectable recurrent DLL3-positive high-grade glioma will receive neoadjuvant tarlatamab prior to planned surgery, followed by adjuvant tarlatamab after surgery. In the neoadjuvant phase, tarlatamab will be administered intravenously using a step-up regimen of 1 mg on Cycle 1 Day 1, followed by 10 mg on Days 8 and 15. Surgery will be performed after a 2-week washout period following the Day 15 dose. Approximately 3 weeks after surgery, tarlatamab will be restarted with step-up dosing of 1 mg on Day 1, followed by 10 mg on Days 8 and 15, then continued at 10 mg intravenously every 2 weeks for up to 6 cycles, with each cycle defined as 4 weeks.
Biological: Tarlatamab
Tarlatamab will be administered by intravenous infusion using a step-up dosing regimen. During the neoadjuvant phase, participants will receive 1 mg on Cycle 1 Day 1, followed by 10 mg on Cycle 1 Day 8 and Day 15. Surgery will be performed after a 2-week washout period following the Day 15 dose. Postoperatively, tarlatamab will be restarted approximately 3 weeks after surgery using step-up dosing with 1 mg on Day 1, followed by 10 mg on Day 8 and Day 15. Thereafter, participants will receive tarlatamab 10 mg intravenously every 2 weeks for up to 6 cycles. Each treatment cycle is defined as 4 weeks. Tarlatamab will be administered as a 60-minute intravenous infusion, followed by a slow bolus flush.
Number of Participants Completing the DLT Evaluation Period and Undergoing Planned Surgery Without a DLT
Number of participants who complete the protocol-defined DLT evaluation period and undergo the planned surgical resection without experiencing a DLT. A participant will be counted only if all criteria are met. DLTs are defined according to protocol-specified criteria.
Time frame: From first neoadjuvant tarlatamab dose through the postoperative safety assessment 7 days after surgery; Cycle 1 is 4 weeks, with dosing on Days 1, 8, and 15 and surgery approximately 2 weeks after Day 15.
Number of Participants With Treatment-Emergent Adverse Events
Number of participants with at least one treatment-emergent adverse event (TEAE). AEs will be coded using MedDRA and severity graded according to NCI CTCAE v5.0, except CRS and ICANS, which will be graded according to ASTCT consensus criteria.
Time frame: From first study intervention through 60 days after cessation of study intervention.
Number of Participants With Treatment-Related Adverse Events
Number of participants with at least one adverse event assessed as related to study intervention. AEs will be coded using MedDRA and severity graded according to NCI CTCAE v5.0, except CRS and ICANS, which will be graded according to ASTCT consensus criteria.
Time frame: From first study intervention through 60 days after cessation of study intervention.
Incidence of all treatment-emergent adverse events and treatment-related adverse events.
Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs) and treatment-related adverse events during the study. Events will be summarized by incidence, type, severity, seriousness, and relationship to tarlatamab.
Time frame: From first study intervention through 60 days after cessation of study intervention.
Number of Participants With Cytokine Release Syndrome by Maximum ASTCT Grade
Number of participants with cytokine release syndrome (CRS), categorized according to the maximum CRS grade experienced during the assessment period using the ASTCT consensus grading criteria.
Time frame: From first study intervention through 60 days after cessation of study intervention.
Number of Participants With ICANS by Maximum ASTCT Grade
Number of participants with immune effector cell-associated neurotoxicity syndrome (ICANS), categorized according to the maximum ICANS grade experienced during the assessment period using the ASTCT consensus grading criteria.
Time frame: From first study intervention through 60 days after cessation of study intervention.
Response rate according to RANO and iRANO criteria.
Percentage of participants achieving a complete response (CR) or partial response (PR) according to RANO and iRANO criteria, as assessed by the investigator using serial MRI examinations.
Time frame: From treatment initiation; MRI at baseline, pre-surgery, and every 8 weeks thereafter until end of treatment or disease progression, assessed up to approximately 7 months.
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from treatment initiation to the first documented disease progression according to RANO/iRANO criteria or death from any cause, whichever occurs first.
Time frame: From treatment initiation to the first documented disease progression per RANO/iRANO criteria or death from any cause, whichever occurs first, assessed up to 24 months.
Overall survival (OS)
Overall survival (OS) is defined as the time from treatment initiation to death from any cause. Participants alive at the time of analysis will be censored at the last date they were known to be alive.
Time frame: From treatment initiation until death from any cause, assessed up to 12 months.
EORTC QLQ-C30 questionnaires.
Assessment of health-related quality of life using the 30-item EORTC QLQ-C30 questionnaire. Scores will be calculated according to the published EORTC scoring guidelines to assess global health status, functioning, and cancer-related symptoms.
Time frame: Baseline, after surgery, and every 3 months thereafter through end of treatment or disease progression.
EORTC QLQ-BN20 questionnaires
Assessment of brain tumor-specific symptoms and functioning using the 20-item EORTC QLQ-BN20 questionnaire. Scores will be calculated according to the published EORTC scoring guidelines to assess brain tumor-related symptoms and functional impairment.
Time frame: Baseline, after surgery, and every 3 months thereafter through end of treatment or disease progression.
Incidence, severity (graded per CTCAE v5.0 and ASTCT criteria for CRS and ICANS), and type of treatment-emergent adverse events occurring during the adjuvant treatment period.
Assessment of treatment-emergent adverse events during adjuvant tarlatamab treatment. Events will be summarized by incidence, type, and severity. Severity will be graded using CTCAE v5.0, except CRS and ICANS, which will be graded using ASTCT criteria.
Time frame: From first postoperative adjuvant tarlatamab dose through 60 days after completion of adjuvant treatment; up to 6 cycles (each cycle is 4 weeks), for an estimated total of approximately 33 weeks.
Start is estimated for Oct 2027; primary completion for May 2029, 19 months later.
Of 166 non-industry phase 1 interventional studies under Glioma, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 87. This study's planned 19 months is below that.
Counting every sponsor, half of 213 studies reached it within 59 months; a quarter within 36 and three quarters within 88.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Oct 2027, on Nov 12, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: AMG 757
Vall d'Hebron Institute of Oncology