Testing Tarlatamab for astrocytic tumor

Exclusion

• −History of allergic reaction attributed to compounds of similar chemical or biologic composition to tarlatamab.
• −Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV), or those who have had a solid organ transplant or allogeneic transplant.
• −ExclusionExclusion criteriaThe things that would prevent someone from taking part.Read more → of hepatitis infection based on the following results and/or criteria (within 3 months prior to the first dose of tarlatamab):
• −Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B).
• −Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B.
• −Positive hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.
• −Concurrent enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in another clinical study, unless it is an observationalObservational studyA study that watches what happens without assigning any treatment.Read more → (non-intervention) clinical study or the follow-up periodFollow-upContinued check-ins after the treatment part is finished.Read more → of an interventional studyInterventional studyA study where participants are given something to see what happens.Read more →.
• −Receipt of any conventional or investigational anticancer therapy within 28 days prior to the first dose of tarlatamab.
• −Any previous treatment with tarlatamab.
• −Other malignancy within the last 5 years with exceptions.
• −Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
• −History of arterial thrombosis within 12 months of first dose of tarlatamab.
• −Patients with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of tarlatamab.
• −History of hypophysitis or pituitary dysfunction.
• −Whole blood transfusions within 120 days prior to enrollment to the study (packed red blood cells and platelet transfusions are acceptable outside of 28 days prior to treatment).
• −Current or prior use of immunosuppressive medications within 14 days before the 1st dose of tarlatamab. Patients receiving systemic corticosteroids must have been on a stable dose of corticosteroids for at least 14 days prior to the 1st dose of tarlatamab.
• −Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, celiac disease, and Wegner syndrome) within the last 2 years. Patients with vitiligo, alopecia, Grave's disease, hypothyroidism stable on hormone replacement, or psoriasis not requiring systemic treatment (within the past 3 years) are not excluded.
• −Any condition that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, would interfere with evaluation of the investigational products or interpretation of patient safety or study results.
• −Receipt of live attenuated vaccines within 30 days prior to the 1st dose of tarlatamab, during the study and for 30 days after the last dose of tarlatamab. Examples include, but are not limited to, vaccines for measles, mumps, and rubella, live attenuated influenza vaccine (nasal), chicken pox vaccine, oral polio vaccine, rotavirus vaccine, yellow fever vaccine, BCG vaccine, typhoid vaccine and typhus vaccine.
• −Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice).
• −Patients unable to remain within one hour of study siteTrial siteA hospital or clinic where a study is actually run.Read more → for additional 48 hours after hospitalization on cycle 1 day 1 and cycle 1 day 8.
• −Patients unable to remain within one hour of any hospital for 72 hours after infusion of tarlatamab on cycle 1 day 1 and cycle 1 day 8.
• −Patients unable to identify home companion who will cohabitate with subject for 72 hours after infusion of tarlatamab on cycle 1 day 1 and cycle 1 day 8.
• −Patients who are pregnant, lactating, or intend to become pregnant during their participation in this study.
• −Patients receiving any systemic chemotherapy or radiotherapy within 28 days prior to study treatment.
• −Unresolved toxicity from prior anti-tumor therapy or prior surgery.
• −Major surgery within 28 days of starting study treatment and patients must have recovered from any effects of any major surgery.