ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-NeoB in Combination With Radiotherapy and Temozolomide in Subjects With Newly Diagnosed Glioblastoma and as a Single Agent in Recurrent Glioblastoma

Quick Facts

Study Start:2024-05-15
Study Completion:2032-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05739942

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

University of California LA
Los Angeles, California, 90095
United States
University of Colorado Denver
Aurora, Colorado, 80045
United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Memorial Sloan Kettering Cancer Ctr
New York, New York, 10065
United States
Univ Hosp Cleveland Medical Center
Cleveland, Ohio, 44106-5028
United States
Uni of Utah Huntsman Cancer Inst
Salt Lake City, Utah, 84103
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-15
Study Completion Date2032-07-01

Study Record Updates

Study Start Date2024-05-15
Study Completion Date2032-07-01

Terms related to this study

Keywords Provided by Researchers

  • Glioblastoma,
  • GBM,
  • Radioligand Therapy,
  • RLT,
  • [68Ga]Ga-NeoB,
  • [177Lu]Lu-NeoB,
  • Temozolomide,
  • TMZ,
  • O-6-methylguanine-DNA methyltransferase,
  • MGMT

Additional Relevant MeSH Terms

  • Newly Diagnosed and Recurrent Glioblastoma