Phase 1 study of DS-5573a

Phase 1

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

• Registration Number: JPRN-jRCT2080222535
• Lead Sponsor: DAIICHISANKYO Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 57

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 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, 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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