A Phase 1 Study of DS-1001b in Patients with IDH1 Mutated Gliomas
- Conditions
- Glioma
- Registration Number
- JPRN-jRCT2080223424
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 18
1) Subjects must have histologically confirmed glioma with an IDH1-R132 mutation.
2) Subjects must have disease that has recurred or progressed following standard treatment including radiation therapy.
3) Subjects must have measurable lesion(s) as per RANO criteria.
4) Subjects must have ECOG PS of 0 to 2.
1) Subjects with significant symptoms of increased intracranial pressure.
2) Subjects who have active another neoplasm.
3) Subjects with active infection requiring systemic treatment.
4) Subjects with a history of severe cardiac disease
5) Subjects who have received prior treatment with any therapy targeting mutant IDH1.
6) Subjects who have received other investigational drug treatment within 3 weeks prior to the first dose of study treatment.
7) Female subjects who are pregnant or breast feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method other<br>To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of DS-1001b
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>pharmacodynamics<br>1) To assess the safety and tolerability of DS-1001b <br>2) To characterize the pharmacokinetic (PK) profile of DS-1001b <br>3) To characterize the pharmacodynamic (PDy) effect of DS-1001b on 2-HG levels <br>4) To assess the preliminary anti-tumor activity of DS-1001b <br><br>Tumor response will be determined using the response assessment criteria published by Response Assessment in Neuro-Oncology (RANO) working group.