Dose Finding Study of [177Lu]Lu-NeoB in Combination With RT and TMZ in Newly Diagnosed GBM.

• Status: Not yet recruiting
• Trial end date: 2025-01-17
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate different doses of [177Lu]Lu-NeoB in combination with RT and TMZ in participants with newly diagnosed GBM with methylated or unmethylated promoter to assess the safety and efficacy of [177Lu]Lu-NeoB in combination with the SoC 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Temozolomide

Criteria

Inclusion Criteria:

• Signed informed consent must be obtained prior to participation in the study

• Histologically confirmed Glioblastoma according to WHO classification established following either a surgical resection or biopsy

• Adequate bone marrow and organ function as defined by the following laboratory values obtained within =< 14 days prior to receiving the first study treatment

• Presence of gadolinium enhancement at the tumor region in the pre-surgery MRI

• Karnofsky performance status >= 60%

Exclusion Criteria:

• Additional, concurrent, or active therapy for Glioblastoma outside of the present study

• Administration of a radiopharmaceutical with therapeutic intent within a period corresponding to 10 half-lives of the radionuclide used prior to injection of [68Ga]Ga-NeoB

• History or current diagnosis of impaired cardiac function

• History of another active malignancy in the previous 3 years prior to study entry

• Known hypersensitivity to any of the study treatments, their excipients or dacarbazine