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Special Notice 8AN Expired 1 notice 1 document

Recurrent Glioblastomas NIMH26000869

Solicitation NIMH26000869 Copied Notice ID 1997a4d5032f4298a0296fde9f1ece9c Copied HEALTH AND HUMAN SERVICES, DEPARTMENT OF — NATIONAL INSTITUTES OF HEALTH
SAM.gov
Posted
Mar 31, 2026
Deadline
Apr 15, 2026
Set-aside
8AN
NAICS
541715
PSC
R499

Summary

AI-generated · Apr 01, 2026

Evaluate progression-free and overall survival in participants with recurrent glioblastoma treated with LMP744 compared to historic controls, and perform pharmacodynamic analyses by comparing molecular and metabolic profiles in tissue, CSF, and plasma before and after exposure to LMP744 to determine pharmacologic responses and identify features predictive of drug response, with findings guiding the design of Phase III trials.

This is the first clinical trial of the novel indenoisoquinolone CMYC/TOPOISOMERASE 1 inhibitor LMP744 in recurrent glioblastoma. Continuous, objective safety monitoring will be conducted for all enrolled patients (40 total), and results will provide objective pharmacologic response data and early efficacy signals versus historical controls to address the urgent need for effective therapies.

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.

From Special Notice posted on Mar 31, 2026

Notice history

1
  1. Special Notice LATEST Posted Mar 31, 2026 View

Details

Solicitation number NIMH26000869
Notice ID 1997a4d5032f4298a0296fde9f1ece9c
Notice type Special Notice
Product / Service (PSC) R499
NAICS 541715
Set-aside 8(a) Sole Source
Place of performance Bethesda, Maryland
Archive date Apr 30, 2026

Award Information

Not yet awarded

Documents

1
View on SAM.gov

Contacts

primary
Joseph Kennedy

Email

Agency

HEALTH AND HUMAN SERVICES, DEPARTMENT OF
NATIONAL INSTITUTES OF HEALTH

Place of Performance

Bethesda, Maryland 20814
USA

Dates

Posted Mar 31, 2026 4 months ago
Last Updated Aug 06, 2026 1 day ago
Due Apr 15, 2026 3 months ago