Clinical trial · Interventional
Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors
Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors Harboring Either a ROS1 or NTRK Fusion Gene
NCT02675491CI-TRIAL-00083792completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of DS-6051b in Japanese subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Malignant Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DS-6051b | Drug | Taletrectinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DS-6051b
- description
- Drug: DS-6051b 400 mg or 800 mg daily
- interventionNames
- Drug: DS-6051b
Primary outcomes (1)
- measure
- number and severity of adverse events
- timeFrame
- Day 1 through 28 days after last dose
- description
- number and severity of treatment emergent adverse events
Secondary outcomes (5)
- measure
- Cmax of DS-6051a
- timeFrame
- Days 1 and 15 of Cycle 1
- description
- Maximum concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve (AUC) and CL/F for DS-6051a (a free base form of DS-6051b) will be assessed on Days 1 and 15 of Cycle 1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced solid malignant tumors that are refractory to standard therapy or for which no standard therapy is available. * An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. Exclusion Criteria: * Previously had or currently has any of the following diseases: Cardiac failure (NYHA Functional Classification ≥ Class III), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary/peripheral artery disease, pulmonary thrombosis, uncontrolled deep vein thrombosis, clinically severe thromboembolic event, or autoimmune disease requiring treatment. * Previously had or currently has clinically severe pulmonary disease (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, radiation pneumonia). * Severe or uncontrolled concomitant disease. * Clinically active brain metastases or central nervous system tumor requiring steroid or anticonvulsant treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.