AG-120 + AG-881 for Brain Tumor

Recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Institut de Recherches Internationales Servier

Must not be taking: IDH inhibitors, Avastin

Disqualifiers: Recent chemotherapy, Recent radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

49 Participants Needed

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AG-120 or AG-881 orally for 28 days prior to surgery

4 weeks

Continuous dosing

Surgery

Surgical resection of glioma tumors is performed

Post-Surgery Treatment (optional)

Participants have the option to continue treatment with AG-120 or AG-881

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AG-120
• AG-881

Trial Overview 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.

Participant Groups

Group I: AG-881 Experimental Treatment 1 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-120 Experimental Treatment 1 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-Surgery Active Control 1 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:

• Acute myeloid leukemia (AML) with a susceptible IDH1 mutation

Who Is Running the Clinical Trial?

Institut de Recherches Internationales Servier

Lead Sponsor

Trials

91

Recruited

67,100+