CLINICAL TRIALS PROFILE FOR AG-881

Clinical Trials for AG-881

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02481154 ↗	Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation	Active, not recruiting	Agios Pharmaceuticals, Inc.	Phase 1	This study evaluates the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in Gliomas, that harbor an IDH1 and/or IDH2 mutation.
NCT02481154 ↗	Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation	Active, not recruiting	Institut de Recherches Internationales Servier	Phase 1	This study evaluates the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in Gliomas, that harbor an IDH1 and/or IDH2 mutation.
NCT02492737 ↗	Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation	Completed	Agios Pharmaceuticals, Inc.	Phase 1	The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in advanced hematologic malignancies that harbor an IDH1 and/or IDH2 mutation
NCT03343197 ↗	Study of AG-120 and AG-881 in Subjects With Low Grade Glioma	Active, not recruiting	Agios Pharmaceuticals, Inc.	Phase 1	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.
NCT03343197 ↗	Study of AG-120 and AG-881 in Subjects With Low Grade Glioma	Active, not recruiting	Institut de Recherches Internationales Servier	Phase 1	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.
NCT03960502 ↗	A Safety and Pharmacokinetic Study of AG-881 in Healthy Male Participants Following Administration of a Single Oral Dose of [14C] AG-881 and Concomitant Intravenous Microdose of [13C315N3] AG-881	Completed	Agios Pharmaceuticals, Inc.	Phase 1	The purpose of this Phase I, open-label study is to evaluate the absorption, distribution, metabolism, excretion, absolute bioavailability, and to characterize the metabolites of AG-881 in healthy male participants following administration of a single oral dose of [14C] AG-881 and a concomitant intravenous microdose of [13C315N3] AG-881.

Clinical Trial Conditions for AG-881

Condition Name

Condition Name for
Intervention	Trials
Healthy Volunteers	2
Glioma	2
Hematologic Malignancies	1
Hepatic Impairment	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Glioma	3
Hematologic Neoplasms	1
Astrocytoma	1
Preleukemia	1

Clinical Trial Locations for AG-881

Trials by Country

Trials by Country for
Location	Trials
United States	48
Canada	3
United Kingdom	2
France	2
Italy	2

Trials by US State

Trials by US State for
Location	Trials
Texas	4
Massachusetts	4
California	4
New York	4
Arizona	3

Clinical Trial Progress for AG-881

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	1
Phase 1	9

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	5
Not yet recruiting	2
Active, not recruiting	2

Clinical Trial Sponsors for AG-881

Sponsor Name

Sponsor Name for
Sponsor	Trials
Agios Pharmaceuticals, Inc.	8
Institut de Recherches Internationales Servier	5
Merck Sharp & Dohme LLC	1

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	9
Other	5