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Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-8895a in Subjects with Advanced Solid Tumor

Phase 1 study of DS-8895a

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.
- ECOG Performance Status(PS)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, deep-vein thrombosis or clinically severe thromboembolic events, 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.

Both

Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.

investigational material(s)
Generic name etc : DS-8895a
INN of investigational material :
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administration for Investigational material : Intravenous infusion

Safety, tolerability, and pharmacokinetics
- The safety of DS-8895a will be assessed by CTCAE.
- The maximum tolerated dose of DS-8895a, and the recommended dose of DS-8895a for the following clinical studies will be estimated.
- Pharmacokinetics of DS-8895a will be evaluated by following the instruction of the study protocol.

- Incidence of anti-DS-8895a antibody
- Exploratory assessment of DS-8895a-related biomarkers
- Exploratory assessment of tumor response to DS-8895a

- Incidence of anti-DS-8895a antibody is measured by analysis of samples collected from subjects based on the study protocol schedule
- Exploratory assessment of DS-8895a-related biomarkers, which are assessed by analysis of samples collected from subjects based on the study protocol schedule
- Tumor response will be assessed by RECIST