Advanced Solid Malignant Tumors
Conditions
Keywords
Advanced solid malignant tumors, phase 1, oncology, refractory, no standard treatment
Brief summary
This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of DS-1123a in Japanese subjects with advanced solid tumors.
Interventions
DRUGDS-1123
starting intravenous (IV) dose of 0.1 mg/kg.
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean residence time (MRTinf) | Cycles 1, 2: Days 1,2, 4, 8, 15 | — |
| Drug clearance (CL) | Cycles 1, 2: Days 1,2, 4, 8, 15 | — |
| Volume of distribution (Vz) | Cycles 1, 2: Days 1,2, 4, 8, 15 | — |
| Maximum concentration (Cmax) | Cycles 1, 2 : Days 1,2, 4, 8, 15 | — |
| Number and severity of treatment emergent adverse events (TEAEs) | Day 1 to Day 31 | — |
| Time of maximum concentration (Tmax) | Cycles 1, 2: Days 1,2, 4, 8, 15 | — |
| Elimination rate constant (Kel) | Cycles 1, 2: Days 1,2, 4, 8, 15 | — |
| area under the curve AUClast | Cycles 1, 2: Days 1,2, 4, 8, 15 | pharmacokinetics profile |
| Area under the curve (AUCtau) | Cycles 1, 2: Days 1,2, 4, 8, 15 | — |
| Area under the curve (AUCinf) | Cycles 1, 2: Days 1,2, 4, 8, 15 | — |
| Half-life (T1/2) | Cycles 1, 2: Days 1,2, 4, 8, 15 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cytokines expression | Cycle 1: Days 1, 2, 15, 16; Cycle 2: Days 1, 2 | Change in DS-1123a biomarkers Cytokines expression on Cycle 1: Days 1, 2, 15, 16; Cycle 2: Days 1, 2 |
| DS-1123a antibody | Cycle 1: Days 1,15; Cycles 2: Day 1; Stop date, final follow-up date | DS-1123a antibody on Cycle 1: Days 1,15; Cycles 2 and on: Day 1, Stop date, final follow-up date |
Countries
Japan
Outcome results
None listed