DS8895-A-J101

About this trial

Last updated 6 years ago

Study ID

DS8895-A-J101

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

Accepting

20+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 8 years ago

This is an open-label, sequential dose escalation and expansion study to evaluate the safety, tolerability, and pharmacokinetics of DS-8895a 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.

Phase 1 Study of DS-8895a in Subjects With Advanced Solid Tumors