OncoMatch/Clinical Trials/NCT07243470
Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors
Is NCT07243470 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Tarlatamab and Temozolomide (TMZ) for glioma.
Treatment: Tarlatamab · Temozolomide (TMZ) — 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. Only patients with DLL3 positive tumor on IHC can be enrolled in the therapeutic part. This pre-screening must be optimally performed during the ongoing treatment line i.e. before documented progression to not delay treatment starts at time of progression. Tumor samples (surgery or biopsy specimen) will be sent to a central lab for IHC testing.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: DLL3 overexpression (at least 1+ on IHC)
Tumors expressing DLL3 based on IHC staining performed on archival tumor sample i.e. at least 1+ on IHC [patient with no tumor expression of DLL3 are not eligible].
Prior therapy
Must have received: radiotherapy — standard therapy
Confirmed progressive or refractory disease after at least one line of standard therapy containing radiotherapy and for which no further effective standard therapy exists.
Cannot have received: DLL3-directed therapy
Prior treatment with a DLL3-directed therapy. Note: Prior treatment with TMZ is not an exclusion criteria.
Lab requirements
Blood counts
ANC ≥1.5 G/L (no growth factor support within 7 days); Platelet count ≥ 100 G/L (unsupported > 7 days); Hemoglobin ≥ 9.0 g/dL (unsupported > 7 days)
Kidney function
Adult: Creatinine clearance as per CKD-EPI > 30 mL/min/1.73 m²; Pediatric: Creatinine <1.5 ULN for age or GFR > 60 mL/min/1.73m2
Liver function
Total bilirubin ≤1.5 x ULN (≤ 3.0 × ULN for patients with Gilbert's syndrome); ALAT ≤ 3 x ULN; ASAT ≤ 3 x ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥50% at baseline
Adequate end organ function according to laboratory values defined below : ... Hematologic criteria : ... Renal and hepatic function : ... Adequate cardiac function defined by Left ventricular ejection fraction (LVEF) ≥50% at baseline.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify