A Phase II study of DS-1001b in Patients with 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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225243

Enrollment

Registered

2020-06-24

Start date

2020-07-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glioma

Interventions

investigational material(s) Generic name etc : DS-1001b INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational materia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Has a histopathologically documented IDH1 mutated WHO grade II glioma according to the 2016 WHO classification 2.Has confirmed IDH1 mutation at the R132 locus by central laboratory testing. 3.Has no prior anticancer (including chemotherapy and radiotherapy) for glioma except craniotomy or biopsy. 4.Has at least 1 measurable and non-enhancing lesion. 5.Has an interval of at least 90 days from the latest surgery. 6.Has no sign of malignant transformation including the appearance of enhancing lesion and/or rapid growth of non-enhancing lesion. 7.Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.

Exclusion criteria

Exclusion criteria: 1.Has had a histopathological diagnosis of WHO grade III or IV glioma. 2.Has had a contrast enhancing lesion on brain MRI. 3.Has received a prior treatment with any mutant IDH1 inhibitor. 4.Has received other investigational products within 28 days before the start of the study drug treatment. 5.Has multiple primary malignancies. 6.Has an active infection requiring systemic treatment. 7.Has a history of clinically significant cardiac disease. 8.Is a pregnant or lactating woman

Design outcomes

Primary

Measure	Time frame
efficacy safety Overall response rate (ORR) assessed by Independent Efficacy Review Committee Number of participants with treatment-emergent adverse events (TEAEs) during the study	—

Secondary

Measure	Time frame
pharmacokinetics pharmacodynamics efficacy 1)Clinical benefit rate 2)Percentage change in tumor volume 3)Time to response 4)Duration of response 5)Time to treatment failure 6)Progression-free survival 7)Overall survival 8)Pharmacokinetic (PK) profile including AUC, Cmax, Tmax of DS-1001a 9)2-hydroxyglutarate concentration Tumor response will be determined using the response assessment criteria published by Response Assessment in Neuro-Oncology (RANO) working group.	—

Measure

Time frame

pharmacokinetics pharmacodynamics efficacy 1)Clinical benefit rate 2)Percentage change in tumor volume 3)Time to response 4)Duration of response 5)Time to treatment failure 6)Progression-free survival 7)Overall survival 8)Pharmacokinetic (PK) profile including AUC, Cmax, Tmax of DS-1001a 9)2-hydroxyglutarate concentration Tumor response will be determined using the response assessment criteria published by Response Assessment in Neuro-Oncology (RANO) working group.

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Countries

Japan

Contacts

Public ContactContact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial_jp@daiichisankyo.com+81-3-6225-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026