Solid Tumors
Conditions
Keywords
advanced solid tumor, Phase 1, Oncology
Brief summary
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.
Interventions
DRUGDS-8895a
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 |
|---|---|---|
| number of participants experiencing dose limiting toxicities | day 1 through day 28 | to investigate the safety of DS-8895a reporting on frequency and seriousness of treatment emergent adverse events |
| number of participants experiencing clinical or laboratory adverse events | from start of treatment to end of treatment, on expected average 12 weeks | to investigate the safety of DS-8895a reporting on frequency and seriousness of treatment emergent adverse events |
| serum pharmacokinetics of DS-8895a | Cycle 1 - days 1, 2, 4, 8 and 15; Cycle 2-days 1, 2, 4, 8 and 15; Cycle 3 and on- days 1; end of study; 45 days post last dose | pharmacokinetics (Area Under the Curve-AUC, Terminal Elimination half-life-t1/2, Total Body Clearance) of DS-8895a in Japanese subjects with advanced solid tumors, and also to investigate the recommended dose of DS-8895a for subsequent clinical studies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pharmacodynamic effects in tumors | baseline and day 1 of cycle 2 | effects on tumor cells will be determined at baseline and day 1 of cycle 2 |
| level of anti-DS-8895a (HAHA) antibody | Cycle 1 days 1 and 15; Cycle 2 day 1; end of study; 45 days post-last-dose | Human anti-human antibody (HAHA) profile for DS-8895a \[Time Frame: Cycle 1 - days 1, and 15; Cycle 2 and on - days 1; end of study; 45 days post last dose\] The presence of HAHA (anti-DS-8895a neutralizing antibody) in serum will be assessed |
| objective response rate | every 6 weeks | sum of complete response and partial response rates measured every 6 weeks until study drug discontinuation |
| disease control rate | every 6 weeks | proportion of subjects with the best overall response of stable disease or better will be measured every 6 weeks until study drug discontinued. |
| pharmacodynamic effects in blood | day 1 and 2 | effects on blood will be determined at day 1 and 2 of each cycle |
Countries
Japan
Outcome results
None listed