Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas

Conditions

Glioma

Keywords

DS-1001b, IDH1 mutation, Developmental Phase I, Glioma

Brief summary

This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132 mutations.

David A. Reardon, Yoshie Umemura, Katherine B. Peters, Ying Mao, Yong-Yi Cen et al. (8 authors)

Neuro-Oncology2025-11-01

10.1093/neuonc/noaf201.0516

The first-in-human phase I study of a brain-penetrant mutant IDH1 inhibitor DS-1001 in patients with recurrent or progressive IDH1-mutant gliomas

Atsushi Natsume, Yoshiki Arakawa, Yoshitaka Narita, Kazuhiko Sugiyama, Nobuhiro Hata et al. (25 authors)

Neuro-Oncology2022-06-2076 citations

10.1093/neuonc/noac155

ACT-14 A FIRST-IN-HUMAN STUDY OF MUTANT IDH1 INHIBITOR DS-1001B IN PATIENTS WITH RECURRENT GLIOMAS

Yoshiki Arakawa, Yohei Mineharu, Toshihiko Wakabayashi, Atsushi Natsume, Yasuji Miyakita et al. (20 authors)

Neuro-Oncology Advances2019-12-01

10.1093/noajnl/vdz039.063

Phase I study of a brain penetrant mutant IDH1 inhibitor DS-1001b in patients with recurrent or progressive <i>IDH1</i> mutant gliomas.

Atsushi Natsume, Toshihiko Wakabayashi, Yasuji Miyakita, Yoshitaka Narita, Yohei Mineharu et al. (19 authors)

Journal of Clinical Oncology2019-05-2023 citations

10.1200/jco.2019.37.15_suppl.2004

Interventions

DRUGDS-1001b

Generic not assigned

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

No

Inclusion criteria

1. Has histologically confirmed glioma with an IDH1-R132 mutation 2. Has disease that has recurred or progressed following standard treatment including radiotherapy 3. Has measurable lesion(s) as per RANO criteria 4. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Exclusion criteria

1. Has significant symptoms of increased intracranial pressure 2. Has another active neoplasm 3. Has active infection requiring systemic treatment 4. Has a history of severe cardiac disease 5. Has had prior treatment with any inhibitor targeting mutant IDH1 6. Has had investigational drug treatment within 4 weeks prior to the first dose of study treatment 7. Is a pregnant or lactating female

Design outcomes

Primary

Measure	Time frame
Percentage of participants with dose limiting toxicities	21 days

Secondary

Measure	Time frame	Description
Percentage of participants experiencing an adverse event (AE)	up to 36 months	AEs temporally associated with DS-1001b treatment
Area under the concentration curve (AUC) for DS-1001b	up to 36 months	—
Maximum plasma concentration (Cmax) for DS-1001b	up to 36 months	—
Time to maximum plasma concentration (Tmax) for DS-1001b	up to 36 months	—
Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b	Baseline, up to 36 months	—
Tumor response to DS-1001b based on Response Assessment in Neuro-Oncology Criteria (RANO)	up to 36 months	—

Countries

Japan

Contacts

STUDY_DIRECTORGlobal Clinical Leader

Daiichi Sankyo

Outcome results

None listed