Testing the Combination of Anti-cancer Drugs Actimab-A and Cemiplimab (REGN2810) to Improve Outcomes for Patients With Recurrent Glioblastoma

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07422363
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Recurrent Glioblastoma, IDH-Wildtype
  • Recurrent Gliosarcoma
  • Recurrent WHO Grade 4 Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Actinium Ac 225 Lintuzumab — RADIATION
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Cemiplimab — BIOLOGICAL
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo PET/CT and/or SPECT/CT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Radiologic Imaging Procedure — PROCEDURE
    Undergo radiologic imaging
  • Single Photon Emission Computed Tomography — PROCEDURE
    Undergo SPECT/CT

Study Details

This phase I trial studies the side effects and best dose of Actimab-A when given together with cemiplimab (REGN2810) in treating patients with glioblastomas that have come back after a period of improvement (recurrent). Actimab-A consists of the monoclonal antibody lintuzumab combined with the radioactive drug actinium Ac 225. Lintuzumab specifically binds to the cell surface antigen CD33 which is found on the glioblastoma cells and delivers the actinium Ac 225. This may allow the glioblastoma to be found and treated by Actimab-A. Immunotherapy with monoclonal antibodies, such as cemiplimab (REGN2810), may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving Actimab-A with cemiplimab (REGN2810) may be safe, tolerable and/or effective in treating recurrent glioblastoma.

Key Dates

Start date
Jun 28, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Actimab-A, cemiplimab)
    Patients receive Actimab-A IV over 30 minutes on either days 1 and 22 of cycles 1-3, days 1 and 22 of cycles 1 and 2, or days 1 and 22 of cycle 1 and day 1 of cycle 2. Patients also receive cemiplimab IV over 30 minutes on days 1 and 22 of each cycle. Cycles repeat every 42 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and radiologic imaging throughout the study and PET/CT on study. Patients may also optionally undergo SPECT/CT on study.

Primary Outcome Measure

Dose limiting toxicities (DLTs) [ Time Frame: Up 6 weeks after initiating treatment ]

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