Trial Profile

A Phase I, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation

Status: Recruiting

Phase of Trial: Phase I

Latest Information Update: 13 Jun 2025

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At a glance

Drugs Ivosidenib (Primary)
Indications Acute myeloid leukaemia; Haematological malignancies; Myelodysplastic syndromes
Focus Adverse reactions; First in man; Registrational; Therapeutic Use
Sponsors Agios Pharmaceuticals

08 Jun 2025 Planned End Date changed from 1 Aug 2025 to 1 Mar 2026.
08 Jun 2025 Planned primary completion date changed from 1 Feb 2025 to 1 Mar 2026.
24 Oct 2023 According to a Servier media release, the U.S. Food and Drug Administration (FDA) has approved TIBSOVO (ivosidenib tablets) for the treatment of patients with isocitrate dehydrogenase 1 (IDH1)-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS),based on data from this trial.

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