MedTrace Logo

Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma

NCT05739942 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-05-14

No results posted yet for this study

Summary

This study will investigate different doses of \[177Lu\]Lu-NeoB in combination with RT and TMZ in participants with newly diagnosed glioblastoma, with methylated or unmethylated promoter, to assess the safety and efficacy of \[177Lu\]Lu-NeoB in combination with the SoC and in recurrent glioblastoma as single agent, to identify the recommended dose and to also explore the safety of the PET imaging agent \[68Ga\]Ga-NeoB and characterize its uptake in the tumor area.

Conditions

  • Newly Diagnosed and Recurrent Glioblastoma

Interventions

DRUG

[177Lu]Lu-NeoB

Radiopharmaceutical solution for infusion

DRUG

[68Ga]Ga-NeoB

Either provided as Kit for the radiopharmaceutical preparation of \[68Ga\]Ga-NeoB or as ready to use radiopharmaceutical solution for injection

OTHER

Temozolomide

Capsules/ lyophilized powder in single-dose vial for reconstitution.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2028-11-08
Completion
2028-11-08
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Italy
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Companies

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 NCT05739942 on ClinicalTrials.gov