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

A Phase 1 Study of DS-1001b in Patients With IDH1 Mutated Gliomas

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.

Study Overview

• Status: Completed
• Conditions: Glioma
• Intervention / Treatment: Drug: DS-1001b

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • National Cancer Center Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Drug DS-1001b; Oral administration	Drug: DS-1001b; Generic not assigned; Other Names: Investigational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants with dose limiting toxicities	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants experiencing an adverse event (AE)	AEs temporally associated with DS-1001b treatment	up to 36 months
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

Collaborators and Investigators

• Sponsor: Daiichi Sankyo
• Collaborators: Daiichi Sankyo, Inc.
• Investigators: Study Director: Global Clinical Leader, Daiichi Sankyo

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2017
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): July 16, 2026

Study Registration Dates

• First Submitted: January 18, 2017
• First Submitted That Met QC Criteria: January 20, 2017
• First Posted (Estimated): January 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: July 24, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Glioma; DS-1001b; IDH1 mutation; Developmental Phase I
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: DS1001-A-J101; 163479 (Registry Identifier: JAPIC CTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No