AG-120 + AG-881 for Brain Tumor

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Institut de Recherches Internationales Servier

No Placebo Group

Trial Summary

What is the purpose of this trial?Study to evaluate the suppression of 2-HG (2-hydroxyglutarate) in IDH-1 mutant gliomas in resected tumor tissue following pre-surgical treatment with AG-120 or AG-881.

Eligibility Criteria

This trial is for adults with a confirmed diagnosis of low-grade glioma (a type of brain tumor) that has not been enhanced by previous treatments. Participants must have a specific gene mutation (IDH1 R132H), be fit for surgery but not in urgent need, and have an expected survival time of over 12 months. They should not have had radiation within the last 6 months or any prior treatment with IDH inhibitors or certain other cancer drugs.

Inclusion Criteria

I can care for myself but may need occasional assistance.

I am a candidate for surgery, but it's not urgent and can be scheduled within 2-4 months.

My cancer has a specific IDH1 mutation and I know my 1p19q and ATRX mutation status.

+4 more

Exclusion Criteria

I have been treated with an IDH inhibitor before.

I haven't taken cancer drugs or experimental treatments within the last month.

I have not had radiation in the last 6 months, but I may have had a biopsy or surgery.

+1 more

Participant Groups

The study tests AG-120 and AG-881's effectiveness at reducing levels of a substance called 2-HG in tumors from patients with IDH-1 mutant gliomas. Before surgical removal, participants will receive one of these drugs to see how well it suppresses this substance in their tumor tissue.

3Treatment groups

Experimental Treatment

Active Control

Group I: AG-881Experimental Treatment1 Intervention

AG-881 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle prior to surgery. Following surgery, subjects will have the option to receive treatment with AG-881.

Group II: AG-120Experimental Treatment1 Intervention

AG-120 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle prior to surgery. Following surgery, subjects will have the option to receive treatment with AG-120 .

Group III: No Treatment Pre-SurgeryActive Control1 Intervention

Subjects will not receive treatment prior to surgery. Following surgery, subjects will have the option to receive treatment with AG-120 or AG-881.

AG-120 is already approved in United States for the following indications:

🇺🇸 Approved in United States as Tibsovo for: