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LMP744 for Recurrent Glioblastoma

This study is testing a drug called LMP744 for people with glioblastoma, a type of brain cancer, that has returned after previous treatment. Glioblastoma can be very serious, and researchers want to see if LMP744 can help kill tumor cells. The study is open to adults aged 18 to 99 who have recurrent glioblastoma (IDH-wildtype). The main goal is to see if LMP744 can cause a partial response (at least 50% tumor shrinkage) or a complete response (100% tumor shrinkage) in participants, measured over 5 years. The current status of the study is unclear, and it plans to enroll 40 participants.

Study design
This is an interventional study with a planned enrollment of 40 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo a biopsy to confirm recurrent glioblastoma, receive LMP744 for 5 days, have another surgery for tissue collection, and then continue LMP744 cycles (5 days on, 23 days off) for up to 12 cycles, followed until death.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed until death, with the primary endpoint measured at 5 years.

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NCT07416188

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

Recruiting
PHASE1Ages 18–99InterventionalTreatment
National Institute of Neurological Disorders and Stroke (NINDS)
~40 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:LMP744Conventional Surgery or Biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Partial response (>=50% disease reduction) or complete response (100% disease reduction) based on RANO 2.0 criteria
Measured over 5 years

Conditions

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

Explore related trials

GlioblastomaIDH1 wt Allele

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Sadhana Jackson, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Neurological Disorders and Stroke (NINDS)

Who to contact

Sadhana Jackson, M.D.
[email protected]
(301) 594-7037
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Partial response (>=50% disease reduction) or complete response (100% disease reduction) based on RANO 2.0 criteria5 years

    As ORR is associated with survival experience, this endpoint allows for objective evaluation of efficacy of LMP744 in this proof-of-concept phase 2 trial