NCT07416188RecruitingPhase 1/2

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

Phase 1/Phase 2 Open Label Trial of a Novel Indenoisoquinolone C-MYC/TOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 1/2
Study type: Interventional
Enrollment: 40 (estimated)
First submitted: 14 Feb 2026
Start date: 15 Jul 2026
Primary completion date: 31 Dec 2030
Lead sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Diseases: Glioblastoma
NCT number: NCT07416188

What you commit to

Study type: Interventional · Phase 1/2
Planned participants: 40
From 15 Jul 2026 to the primary completion date, 31 Dec 2030
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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
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)
Active infection requiring systemic antibacterial, antiviral or antifungal therapy \<7 days prior to initiation of study drug
Solid organ or tissue transplant recipients

Other illness

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)
Additional malignancy diagnosed or requiring active treatment within 1 year of screening
Active autoimmune disease that requires systemic treatment within 2 years of screening
Human Immunodeficiency Virus (HIV)
- Known history of HIV
- Positive HIV 1/2 at screening.
Active Hepatitis B or Hepatitis C infection at screening

Lab values

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)

Other

An individual who meets any of the following criteria will be excluded from participation in this study:
Social situations that would limit compliance with study requirements, such as chronic homelessness
Unable to undergo an MRI scan of the brain
Recipient of autologous or allogeneic T cells

Criteria the registry did not label

INCLUSION CRITERIA:
- Participant must meet all the following inclusion criteria to be deemed eligible for this study:
Participants \>= 18 years of age
Tissue-based diagnosis of recurrent glioblastoma, IDH-wildtype by a neuropathologist
Karnofsky Performance Status (KPS) \>60
Willing to use effective birth control method
- --The effects of LMP744 on developing human fetuses are unknown. Therefore, females of childbearing potential and their male partners must be willing to use an effective method of contraception during the clinical study (hormonal, barrier, surgical, or abstinence) before study enrollment and for 6 months after the last dose of the study drug. If the female becomes pregnant or suspects she is pregnant while participating in this study, she must inform her treating physician immediately.
Agreeable to undergo surgical intervention for brain biopsy and/or resection.
- Initial diagnostic biopsy under 03-N-0164 will be performed to confirm recurrent disease and obtain pre-treatment tissue.
- The surgical intervention may include stereotactic/needle biopsy, open biopsy, and/or resection, as determined by neurosurgical assessment. Only participants for whom gross total resection of tumor is not expected to be achievable will be included in the study.
Willing and able to appoint a durable power of attorney
Able to provide informed consent or have a legally authorized representative (LAR) to provide consent, if incapacitated.

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
National Institutes of Health Clinical Center Coordinator of this site? Confirm its status	Bethesda	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.