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Tarlatamab Treatment Before and After Surgery in Surgically Resectable Recurrent High-grade Glioma: a Window of Opportunity Study (TARLAGLIA Study)

NCT07788677 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-08-26

No results posted yet for this study

Summary

This is a single-arm, window-of-opportunity clinical study evaluating tarlatamab administered before and after surgery in adult participants with surgically resectable recurrent DLL3-positive high-grade glioma. The study is designed to assess the feasibility and safety of neoadjuvant tarlatamab treatment prior to planned tumor resection, as well as the safety and tolerability of postoperative adjuvant tarlatamab.

Eligible participants will have histologically confirmed recurrent high-grade glioma with DLL3-positive tumor expression and will be candidates for neurosurgical resection in whom surgery can be safely delayed to allow neoadjuvant treatment. Participants will receive tarlatamab intravenously using a step-up dosing regimen during the neoadjuvant phase, followed by planned surgical resection after a washout period. After recovery from surgery, participants will restart tarlatamab with step-up dosing and continue adjuvant treatment every 2 weeks for up to 6 cycles.

The primary objective is to evaluate the feasibility and safety of neoadjuvant tarlatamab, including the number of participants able to complete the dose-limiting toxicity evaluation period and undergo planned surgery without experiencing a dose-limiting toxicity. Safety assessments will include adverse events graded according to CTCAE v5.0, as well as cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome graded according to ASTCT criteria.

Secondary objectives include assessment of antitumor activity using RANO and iRANO criteria, progression-free survival, 12-month overall survival, quality of life using EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaires, and the incidence, severity, and type of treatment-emergent adverse events during the adjuvant treatment period.

Conditions

  • High-Grade Glioma (HGG)

Interventions

BIOLOGICAL

Tarlatamab

Tarlatamab will be administered by intravenous infusion using a step-up dosing regimen. During the neoadjuvant phase, participants will receive 1 mg on Cycle 1 Day 1, followed by 10 mg on Cycle 1 Day 8 and Day 15. Surgery will be performed after a 2-week washout period following the Day 15 dose. Postoperatively, tarlatamab will be restarted approximately 3 weeks after surgery using step-up dosing with 1 mg on Day 1, followed by 10 mg on Day 8 and Day 15. Thereafter, participants will receive tarlatamab 10 mg intravenously every 2 weeks for up to 6 cycles. Each treatment cycle is defined as 4 weeks. Tarlatamab will be administered as a 60-minute intravenous infusion, followed by a slow bolus flush.

Sponsors & Collaborators

  • Vall d'Hebron Institute of Oncology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2029-05-01
Completion
2029-05-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07788677 on ClinicalTrials.gov