Phase 1 study of DS-6051b

Phase 1 Study of DS-6051b in Japanese Subjects with Advanced Solid Malignant Tumors Harboring Either a ROS1 or NTRK Fusion Gene

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223057

Enrollment

Registered

2015-12-25

Start date

2016-02-10

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

Advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene

Interventions

investigational material(s) Generic name etc : DS-6051b 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: -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

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.

Design outcomes

Primary

Measure	Time frame
safety Safety, tolerability, and pharmacokinetics -The safety of DS-6051b will be assessed by CTCAE. -The maximum tolerated dose of DS-6051b, and the recommended dose of DS-6051b for the following clinical studies will be estimated. -Pharmacokinetics of DS-6051b will be evaluated by following the instruction of the study protocol.	—

Secondary

Measure	Time frame
safety pharmacokinetics The maximum tolerated dose, the recommended dose of for the following clinical studies, pharmacokinetics, exploratory assessment of tumor response Tumor response will be assessed by RECIST	—

Countries

Japan

Outcome results

None listed

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