A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma

A Phase II Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-naive IDH1 Mutated WHO Grade II Glioma

This Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.

Inclusion Criteria:

• Has a histopathologically documented IDH1 mutated WHO grade II glioma according to the 2016 WHO classification.
• Has confirmed IDH1 mutation at the R132 locus by testing at the central laboratory conducted during the screening period.
• Has no prior anticancer treatment (including chemotherapy and radiotherapy) for glioma except craniotomy or biopsy.
• Has at least 1 measurable and non-enhancing lesion.
• Has an interval of at least 90 days from the latest surgery.
• Has no sign of malignant transformation including the appearance of enhancing lesions and/or rapid growth of non-enhancing lesions.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.

Exclusion Criteria:

• Has had a histopathological diagnosis of WHO grade III or IV glioma.
• Has had a contrast enhancing lesion on brain MRI.
• Has received a prior treatment with any mutant IDH1 inhibitor.
• Has received other investigational products within 28 days before the start of the study drug treatment.
• Has an active infection requiring systemic treatment.
• Has multiple primary malignancies.
• Has a history of clinically significant cardiac disease.
• Is a pregnant or lactating woman.