TARLATEM : Combination of TARLAtamab and TEMozolomide in patients with central nervous system tumors. A multicenter, open-label Phase I/II trial aiming to assess the safety and clinical activity of Tarlatamab in combination with metronomic Temozolomide in adolescents and adults’ patients with high grade brain tumors

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510568-11-00

Acronym

ET23-040

Enrollment

450

Registered

2025-08-21

Start date

2025-11-18

Completion date

Unknown

Last updated

2025-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High grade brain tumors

Brief summary

Phase I: Dose limiting toxicities (DLT) defined as the following adverse event (AE) graded according to NCI CTCAE V5.0 or specific grading system for ICANS and CRS, assessed as related at least to tarlatamab, occurring during the first 2 cycles of treatment (i.e. DLT period is 8 weeks for DL1 or 12 weeks if DL-1 is investigated), Phase II: Objective response rate at 12 weeks (ORR-12W) according to immunotherapy Response Assessment for Neuro-Oncology (iRANO) criteria.

Detailed description

• Duration of response (DOR) • Disease Control Rate (DCR) • Time to Objective Response (ToR) • Progression Free Survival (PFS) • Overall Survival (OS), Nature, incidence and severity of AEs graded using CTCAE V5.0 or specific grading system for ICANS and CRS, Exploratory endpoint: Gene expression including DLL3 by RNASeq, , ctDNA dosing and sequencing, immunomonitoring on PBMC

Interventions

DRUGTEMOZOLOMIDE

DRUGTarlatamab

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase I: Dose limiting toxicities (DLT) defined as the following adverse event (AE) graded according to NCI CTCAE V5.0 or specific grading system for ICANS and CRS, assessed as related at least to tarlatamab, occurring during the first 2 cycles of treatment (i.e. DLT period is 8 weeks for DL1 or 12 weeks if DL-1 is investigated), Phase II: Objective response rate at 12 weeks (ORR-12W) according to immunotherapy Response Assessment for Neuro-Oncology (iRANO) criteria.	—

Measure

Time frame

—

Secondary

Measure	Time frame
• Duration of response (DOR) • Disease Control Rate (DCR) • Time to Objective Response (ToR) • Progression Free Survival (PFS) • Overall Survival (OS), Nature, incidence and severity of AEs graded using CTCAE V5.0 or specific grading system for ICANS and CRS, Exploratory endpoint: Gene expression including DLL3 by RNASeq, , ctDNA dosing and sequencing, immunomonitoring on PBMC	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026