Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 12 years or older at the time of signing the consent form.
• People who have been confirmed by a tissue test (biopsy or surgery sample) to have a malignant (cancerous) brain or central nervous system (CNS) tumour of specific types, including high-grade glioma with a particular gene change (IDH-mutant), other high-grade gliomas, or other high-grade CNS tumours.
• People whose tumour tissue has tested positive for a protein called DLL3 on a laboratory test called IHC (a special staining test done on a stored tumour sample).
• People whose disease has grown or come back after at least one standard treatment that included radiotherapy, and for whom no further effective standard treatment is available.
• People whose tumour can be measured or evaluated on scans according to specific criteria (called iRANO).
• People who meet a minimum level of physical functioning, measured by standard scales appropriate for their age group (confirm with trial site for exact score required).
• People with a life expectancy of at least 3 months.
• People whose blood counts, kidney, liver, and clotting function meet the minimum levels required by the trial's laboratory tests.
• People whose heart is pumping adequately, with a heart function score of at least 50% on an echocardiogram or similar test.
• People with adequate lung function as assessed by the treating doctor, with no significant fluid build-up around the lungs (minor cases managed with a drainage device may be acceptable — confirm with trial site).
• People for whom a stored tumour tissue sample (from a previous surgery or biopsy) is available, containing at least 30% tumour cells, along with the original pathology report.
• People who have stopped all previous cancer treatments and waited the required time before starting the trial (the exact waiting period depends on the type of treatment previously received — confirm with trial site).
• Women who could become pregnant must have a negative pregnancy blood test within 7 days before starting the trial, and must agree to use highly effective contraception from the screening visit until 6 months after the last dose of study treatment, and must not breastfeed during this period.
• Sexually active males must agree to use appropriate contraception during the trial and for 6 months after stopping study treatment.
• People who are able to understand the study, sign a consent form, and agree to follow study procedures; for younger patients, consent from a parent or legal guardian is also required, along with age-appropriate agreement from the patient.
• People who have health insurance coverage.

Who may not be able to join:

• People whose cancer is not located in the brain or central nervous system.
• People diagnosed with a specific type of brainstem tumour called diffuse intrinsic pontine glioma (DIPG).
• People currently being treated with a drug called bevacizumab.
• People who have previously received a treatment that specifically targets the DLL3 protein.
• People whose neurological condition is unstable, or who have needed increasing doses of steroid medication in the 7 days before starting the trial (people on low-dose steroids below a certain threshold may still be eligible — confirm with trial site).
• People who show significant recent bleeding in the brain on their baseline MRI scan (grade higher than 1).
• People whose tumour is considered very large or is causing significant pressure or shifting of brain structures on imaging.
• People with significant digestive system problems that could affect how oral medications are absorbed, such as severe nausea, vomiting, diarrhoea, or conditions like ulcerative disease or malabsorption.
• People who have had an abdominal fistula, a hole in the gastrointestinal tract, or an abdominal abscess within the 6 months before starting the trial.
• People with significant, uncontrolled heart disease, including certain types of heart rhythm problems occurring within the 6 months before starting the trial.
• People with another active cancer, unless it is a minor skin cancer, early-stage cervical cancer, or localised prostate cancer, or unless the person has had no evidence of that cancer for at least 2 years.
• People with a history of inflammation of the pituitary gland or pituitary dysfunction.
• People with a history of severe allergic reactions to certain types of laboratory-made antibody proteins, to products made using a specific cell manufacturing process (Chinese hamster ovary cells), or to any ingredient in the study drug tarlatamab.
• People with a known allergy to any of the study drugs or their ingredients, including dacarbazine or temozolomide (TMZ).
• People still experiencing significant side effects from previous treatments (above a mild level), except for hair loss, nerve-related effects, hearing-related effects, or certain lab value issues already covered in the inclusion criteria.
• People with arterial blood clots or a history of blood clots in the lungs who require blood-thinning medication.
• People with evidence of a lung condition called interstitial lung disease, or active non-infectious lung inflammation (pneumonitis).
• People with a history of repeated or severe lung inflammation, or severe immune-related side effects or infusion reactions from previous immunotherapy treatments.
• People who have received a live vaccine within 4 weeks before starting the trial (certain flu vaccines given by injection may be acceptable — confirm with trial site; nasal spray flu vaccines are not allowed).
• People with an active autoimmune disease, or a history of autoimmune disease that required systemic treatment within the 2 years before starting the trial.
• People with active hepatitis B (unless it is stably managed with specific antiviral medications), active hepatitis C (unless a specific blood test confirms the virus is not present), or HIV infection.
• People who have previously had an organ or bone marrow transplant.
• People with any other medical condition, ongoing infection, or health concern that the treating doctor believes could interfere with the trial results or would not be in the person's best interest.
• Women who are pregnant or breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.