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
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.
This study is single arm study with DS-6051b in approximately 9 subjects with advanced solid
 malignant tumors harboring either a ROS1 or NTRK fusion gene. Safety and tolerability,
 pharmacokinetics (PK), maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) and
 preliminary efficacy of DS-6051b will be evaluated.
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.