Phase 1 study of DS-1123a
- Conditions
- Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.
- Registration Number
- JPRN-jRCT2080223031
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 27
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety, tolerability, and pharmacokinetics<br>-The safety of DS-1123a will be assessed by CTCAE.<br>-The maximum tolerated dose of DS-1123a, and the recommended dose of DS-1123a for the following clinical studies will be estimated.
- Secondary Outcome Measures
Name Time Method -Incidence of anti-DS-1123a antibody<br>-Exploratory assessment of DS-1123a-related biomarkers<br>-Exploratory assessment of tumor response to DS-1123a<br><br>-Tumor response will be assessed by RECIST