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New treatment option for Glioma
Official title Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors
ClinicalTrials.gov ID: NCT07243470
What this study is testing
What is Tarlatamab?
Tarlatamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial is a 2-phase trial designed to evaluate the safety of tarlatamab in combination with a fixed dose of metronomic temozolomide in adolescents and adults with CNS tumors (stratified into two age-based cohorts), and to assess the clinical activity of this therapeutic strategy in three parallel, histology-defined cohorts (IDH-mutant glioma, other gliomas, and other CNS tumors). A pre-screening to detect DLL3 expression by IHC on archival tumor sample must be performed before the therapeutic part.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- I1. Patients aged ≥ 12 years old at time of inform consent signature. I2. Histologically proven diagnosis of central nervous system (CNS) malignant...
- Karnofsky PS for pediatric patients ≥16 years of age ≥ 70%;
- Lansky PS for patients between 12 and 15y: ≥ 70%;
- PS ECOG for adult patients: 0 or 1. I7. Life expectancy ≥ 3 months. I8. Adequate end organ function according to laboratory values defined below...
- Peripheral absolute neutrophil count (ANC) ≥1.5 G/L (without growth factor support within 7 days)
You likely can't join if
- E1. Diagnosis of non-CNS tumor. E2. Diagnosis of diffuse intrinsic pontine glioma. E3. Current treatment with bevacizumab. E4. Prior treatment with a...
- chimeric or humanized antibodies or fusion proteins,
- biopharmaceuticals produced in Chinese hamster ovary cells,
- or any component of the tarlatamab formulation. E14.Known hypersensitivity to any study drug or component of the formulation or to dacarbazine or...
- Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) unless their HBV is stably...
- Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA, or
See the full eligibility criteria
- I1. Patients aged ≥ 12 years old at time of inform consent signature. I2. Histologically proven diagnosis of central nervous system (CNS) malignant tumor: IDH-mutant high-grade glioma, other high-grade glioma, or other...
- Karnofsky PS for pediatric patients ≥16 years of age ≥ 70%;
- Lansky PS for patients between 12 and 15y: ≥ 70%;
- PS ECOG for adult patients: 0 or 1. I7. Life expectancy ≥ 3 months. I8. Adequate end organ function according to laboratory values defined below : Hematologic criteria :
- Peripheral absolute neutrophil count (ANC) ≥1.5 G/L (without growth factor support within 7 days)
- Platelet count ≥ 100 G/L (unsupported for \> 7 days)
- Hemoglobin ≥ 9.0 g/dL (unsupported for \> 7 days) Renal and hepatic function :
- Creatinine
- Adult patient: Creatinine clearance as per CKD-EPI \> 30 mL/min/1.73 m²
- Pediatric patients: Creatinine \ 60 mL/min/1.73m2 GFR based on the Schwartz equation (Mian and Schwartz 2017) or as per institutional guidelines
- Total bilirubin ≤1.5 x ULN (≤ 3.0 × ULN for patients with Gilbert's syndrome)
- Alanine aminotransferase (ALAT) ≤ 3 x ULN; aspartate aminotransferase (ASAT) ≤ 3 x ULN Coagulation function : Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) or activated...
- Cytotoxic and myelosuppressive chemotherapy : ≥21 days (or ≥42 days if prior nitrosourea)
- Metronomic chemotherapy regimen : ≥21 days or ≥5 half-lives of the treatment with the longest half-life (whichever is shorter)
- Targeted agent : ≥21 days or ≥5 half-lives (whichever is shorter)
- Cellular therapy : ≥42 days for any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells) agent
- Antibody therapy : ≥21 days after the last infusion except for bevacizumab for which a wash out period of 3 months is requested
- Radiotherapy :
- ≥14 days since small port radiation therapy (i.e. local palliative)
- ≥84 days since large-field radiation therapy (i.e. TBI, craniospinal, whole abdominal, total lung, ≥50% or greater pelvic radiation, ≥50% marrow space)
- ≥42 days for other substantial bone marrow radiation
- Surgery : Major surgery ≥ 21 days. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumor biopsy and insertion of central venous access devices are not considered major surgery, but for these...
- E1. Diagnosis of non-CNS tumor. E2. Diagnosis of diffuse intrinsic pontine glioma. E3. Current treatment with bevacizumab. E4. Prior treatment with a DLL3-directed therapy. Note: Prior treatment with TMZ is not an...
- chimeric or humanized antibodies or fusion proteins,
- biopharmaceuticals produced in Chinese hamster ovary cells,
- or any component of the tarlatamab formulation. E14.Known hypersensitivity to any study drug or component of the formulation or to dacarbazine or TMZ. E15.Acute and ongoing toxicities from previous therapy that have not...
- Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) unless their HBV is stably controlled on nucleoside analogs (eg entecavir or tenofovir) which...
- Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA, or
- HIV infection E22. Prior organ or bone marrow transplant E23. History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the...
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Bordeaux, France
- Bron, France
- Lille, France
- Lyon, France
- Marseille, France
- Paris, France
- Toulouse, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Bordeaux, France; Bron, France; Lille, France; Lyon, France; Marseille, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.