SAM #NIMH26000869

Clinical Trial Monitoring Services for LMP744 in Recurrent Glioblastoma Patients

This opportunity from the National Institutes of Health (NIH) seeks clinical trial monitoring services for a study of LMP744 in patients with recurrent glioblastoma. - NIH, specifically the National Institute of Neurological Disorders and Stroke (NINDS), is procuring clinical monitoring services for a trial involving the investigational drug LMP744 - Services required include: - Data collection, abstraction, identification, and validation - Clinical monitoring of 40 enrolled patients to assess safety and efficacy - Molecular and metabolic profiling of tissue, CSF, and plasma before and after drug exposure - Continuous safety monitoring and collaboration with clinical teams - Attendance at research meetings - The contract is a small business set-aside under NAICS 541715 - The intended awardee is Emmes Company, LLC (sole source), but the drug LMP744 is manufactured by a separate entity (not named) - Place of performance is primarily NIH facilities in Bethesda, Maryland, with some remote work - Contract period is a base year (May 1, 2026 – April 30, 2027) plus four option years (total five years) - Approximately 1634 service units (monitoring activities) for 40 patients - No specific OEMs named; LMP744 is the investigational product - Estimated contract value likely in the low millions USD

Locations: - National Institutes of Health campus, Bethesda, MD (primary place of performance) - 3100 Center Drive Room 1B59, Bethesda, MD 20892 (contracting office) - 401 N. Washington Street, Suite 700, Rockville, MD 20850 (Emmes Company, LLC address)

Key Requirements: - Clinical trial monitoring expertise - Ability to perform onsite and remote services - Familiarity with clinical research protocols and molecular profiling

Description

The goal of this clinical trial is to evaluate progression-free and overall survival in participants

with recurrent glioblastoma receiving LMP744 compared to historic controls. We will also

directly compare molecular and metabolic profiles of tissue, CSF, and plasma pre- and postexposure to LMP744 to determine pharmacologic responses to the drug in this patient

population. We will also correlate the pre- and post-exposure molecular and metabolic profiles

with clinical response and outcome, to determine which molecular and metabolic features are

predictive of drug response. The latter information will be critical for the design of phase III

clinical trials involving LMP744. Finally, we will evaluate the safety of LMP744 in patients with

recurrent glioblastoma through continuous, objective monitoring. This is the first clinical trial to investigate the role of the novel indenoisoquinolone, CMYC/TOPOISOMERASE 1 inhibitor LMP744 in participants diagnosed with recurrent glioblastoma. Results from this study will provide objective assessment of the pharmacologic response to the drug and provide an initial assessment of efficacy when compared to historical controls. Our goal is to addresses the urgent need for effective therapies for patients with recurrent glioblastoma. Clinical trial monitoring of each enrolled patient (40 total) will be required for accutae assessment of safety for enrolled patients and future patients on study.

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