BridgeMD
New treatment option for Recurrent Glioblastoma
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, given as a monthly, being studied as a potential treatment for recurrent glioblastoma.
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
- Background: Glioblastoma is a common brain cancer in adults. Treatment includes surgery, radiation, and chemotherapy.
- 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
- Participant must meet all the following 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...
You likely can't join 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...
- 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
See the full eligibility criteria
- Participant must meet all the following 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...
- Agreeable to undergo craniotomy for brain biopsy and/or resection --Initial diagnostic biopsy under 03-N-0164 to confirm recurrent disease and obtain pre-treatment tissue. Only participants who were not expected to able...
- 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.
- 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...
- 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's taking place
- Bethesda, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.