Novel Indenoisoquinolone CMYC/TOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma

Recruiting now · Phase 1/Phase 2

Conditions studied: Recurrent Glioblastoma, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, Relapsed Cancer, Recurrent Tumor, Glioblastoma Multiforme, Recurring Glioblastoma, Brain and Central Nervous System Tumors, Glioma, Glioblastomas, Grade IV Astrocytoma, GBM, Recurrent Glioma (Glioblastoma Multiforme), High Grade Glioma, Glioma, Malignant, Brain Cancer

In brief

Background: Glioblastoma is a common brain cancer in adults. Treatment includes surgery, radiation, and chemotherapy. But this cancer can return after treatment and is often fatal. Researchers want to know if a study drug (LMP744) can kill glioblastoma tumor cells. Objective: To test LMP744 in people with glioblastoma. Eligibility: People aged 18 years or older with glioblastoma that returned after treatment. Design: Participants will be screened. They will have a surgery to remove a small sample of tumor tissue (biopsy) from the brain. This will be done under protocol 03-N-0164. They will stay in the clinic for 1 night. They will also have imaging scans and tests of their heart function. Participants will have a central line installed: A flexible tube will be inserted into a vein in the chest. It will be attached to a "port" under the skin. This port will be used to draw blood and give medicines without having to insert new needles into a vein. LMP744 will be given through the central line for 5 days in a row. Participants will remain in the clinic for this time. Participants will then have a second surgery to remove as much of their tumor as possible. They will remain in the clinic until they recover from the surgery. Then they will recover at home after surgery. Participants will return to the clinic to receive the study drug for 5 days in a row through the central line, once a month for up to 12 months. Blood tests, heart function tests, and periodic imaging scans will be repeated during these visits. Participants will continue to have telehealth visits every 3 months after they stop taking the drug.

Key facts

Study ID

NCT07416188

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

40

Starts

2026-07-15

Expected to finish

2032-12-31

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Pregnant and/or nursing females
• -As LMP744 is a novel agent with the potential for teratogenic or abortifacient effects, pregnant and/or nursing females will be excluded from receiving drug
• Significant medical co-morbidities that would compromise the participant s ability to tolerate LMP744 and which cannot reasonably be controlled (per the investigator s judgment, such as poorly controlled chronic kidney disease and/or poorly controlled congestive heart failure)
• Social situations that would limit compliance with study requirements, such as chronic homelessness
• Prior chemotherapy or biologic therapy completed within 4 weeks (6 weeks for nitrosoureas and mitomycin C) or a duration of 5 half-lives (whichever is shorter)
• Additional malignancy diagnosed or requiring active treatment within 1 year of screening
• Unable to undergo an MRI scan of the brain
• Active autoimmune disease that requires systemic treatment within 2 years of screening
• Cardiac disease
• >=2 MIs
• >=2 coronary revascularization procedures
• Cardiac Troponin T or I >= 2x the institutional upper limit of normal at screening
• Ejection fraction <45% on screening echocardiogram
• Chronic hypokalemia (K<2.5 mmol/L)
• Human Immunodeficiency Virus (HIV)
• Known history of HIV
• Positive HIV 1/2 at screening.
• Active Hepatitis B or Hepatitis C infection at screening
• Active infection requiring systemic antibacterial, antiviral or antifungal therapy <7 days prior to initiation of study drug
• Recipient of autologous or allogeneic T cells
• Solid organ or tissue transplant recipients

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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