Phase 1 study of DS-8895a

Phase 1

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

• Registration Number: JPRN-jRCT2080222257
• Lead Sponsor: DAIICHISANKYO Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 38

Inclusion Criteria

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

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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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