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
AG-120, an oral agent targeting IDH1 mutations, is currently in a Phase I clinical trial sponsored by Servier, focusing on advanced hematologic malignancies. The trial's dual-phase design allows for both dose escalation and expansion, which could provide critical data on safety and efficacy. Given the increasing prevalence of IDH1 mutations in hematologic cancers, AG-120 has the potential to capture a significant share of the market for targeted therapies in this space. The competitive landscape includes other IDH inhibitors such as ivosidenib, necessitating a robust differentiation strategy based on clinical outcomes and safety profiles. Diligence should focus on the trial's progress, patient recruitment rates, and any emerging data that could influence market positioning.
Indication: Relapsed or Refractory Acute Myeloid Leukemia (AML)
Modality: small molecule
Target: IDH1 mutation
Sponsor: Institut de Recherches Internationales Servier
Source URL: ClinicalTrials.gov
Source updated: Detailed source ingestion pending
Ingested: Jul 11, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: IDH1 mutation
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Condition raw: Relapsed or Refractory Acute Myeloid Leukemia (AML), Untreated AML, Other IDH1-mutated Positive Hematologic Malignancies, Myelodysplastic Syndromes
Condition normalized: Relapsed or Refractory Acute Myeloid Leukemia (AML), Untreated AML, Other IDH1-mutated Positive Hematologic Malignancies, Myelodysplastic Syndromes
Modality raw: small molecule
Modality normalized: small molecule
Target raw: IDH1 mutation
Target normalized: IDH1 mutation