Study of DS-1123a in Advanced Solid Tumours

Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-1123a in Subjects With Advanced Solid Tumors

This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of DS-1123a in Japanese subjects with advanced solid tumors.

Inclusion Criteria:

• Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.
• Eastern Cooperative Oncology Group performance status (PS) of 0 or 1.

Exclusion Criteria:

• Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment:

  • Cardiac failure (NYHA ≥ ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, deep-vein thrombosis or clinically severe thromboembolic event, or clinically severe pulmonary disease (eg, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, drug induced pneumonia),

• Severe or uncontrolled concomitant disease.

• Clinically active brain metastases defined as symptomatic or requiring treatment.