Recurrent Glioblastoma study: LMP744
Official title Novel Indenoisoquinolone CMYC/TOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT07416188
What this study is testing
What is LMP744?
LMP744 is an investigational medicine being studied as a potential treatment for recurrent glioblastoma. It is designed to stop the growth of tumor cells by blocking specific proteins called C-MYC and topoisomerase 1.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if the drug LMP744 can kill tumor cells and how much of the drug the body can safely handle.
- Who it's for
- Adults aged 18 or older who have glioblastoma that has returned after previous treatment.
- What's involved
- Participants will have a small tumor sample removed, get a port in their chest for medicine, and receive the study drug through an IV for 5 days in a row. They will also have a surgery to remove as much of the tumor as possible and undergo regular blood tests, heart checks, and scans.
- Time commitment
- The study lasts up to 12 months, requiring monthly hospital stays for 5 days of treatment and check-ups every 3 months after the drug stops.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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.
- Agreeable to undergo surgical intervention for brain biopsy and/or resection.
You likely can't join if
- Pregnant and/or nursing females --As LMP744 is a novel agent with the potential for teratogenic or abortifacient effects, pregnant and/or nursing...
- Significant medical co-morbidities that would compromise the participant s ability to tolerate LMP744 and which cannot reasonably be controlled (per...
- 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...
- Additional malignancy diagnosed or requiring active treatment within 1 year of screening
- Unable to undergo an MRI scan of the brain
See the full eligibility criteria
- 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.
- 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.
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.