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Phase 1, Open Label Study to Assess the Safety and Pharmacokinetics of DS-5573a in Japanese Patients with Advanced Solid Malignant Tumors

Phase 1 study of DS-5573a

DAIICHISANKYO Co.,Ltd.

http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html

Interventional

Multi-center, open label study

1

-Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.
-Eastern Cooperative Oncology Group Performance Status of 0 or 1

-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, uncontrolled deep-vein thrombosis or clinically severe thromboembolic event, autoimmune disorders requiring treatment.
-Severe or uncontrolled concomitant disease.
-Clinically active brain metastases defined as symptomatic or requiring treatment.

Both

Advanced solid malignant tumors refractory to standard treatment or for which no standard treatment is available.

investigational material(s)
Generic name etc : DS-5573a
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Intravenous infusion

Safety and pharmacokinetics
-The safety of DS-5573a will be assessed by CTCAE.
-The maximum tolerated dose of DS-5573a, and the recommended dose of DS-5573a for the following clinical studies will be estimated.
-Pharmacokinetics of DS-5573a will be evaluated.

-Incidence of human anti-human antibodies (HAHA) against DS-5573a.
-Assessment of tumor response to DS-5573a.
-Exploratory assessment of DS-5573a-related biomarkers.
Tumor response will be assessed by RECIST.