Advanced Solid Malignant Tumors
Conditions
Keywords
Advanced solid malignant tumor, phase 1, oncology
Brief summary
This is an open-label, sequential dose escalation and expansion study to evaluate the safety, and pharmacokinetics of DS-5573a in Japanese patients with advanced solid malignant tumors.
Interventions
DRUGDS-5573a
Step 1 of this study will use a starting intravenous (IV) dose of 0.1 mg/kg. Eight dose levels are planned, level 1: 0.1 mg/kg, level 1.5: 0.1 mg/kg, 0.3 mg/kg, level 2: 0.3 mg/kg, level 3: 1 mg/kg, level 4: 3 mg/kg, level 5: 10 mg/kg, level 6: 20 mg/kg, level 7: 30 mg/kg. Step 2: 30 subjects will use the dose determined in Step 1.
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, uncontrolled deep-vein thrombosis or clinically severe thromboembolic event, or autoimmune disorders requiring treatment. * Severe or uncontrolled concomitant disease. * Clinically active brain metastases defined as symptomatic or requiring treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects experiencing dose limiting toxicities | Day 1 through Day 28 | Number of subjects experiencing dose limiting toxicities. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events. |
| Number of subjects experiencing adverse events | Day 1 through 45 days after last dose | Number of subjects experiencing adverse events. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events. |
| Pharmacokinetic profile of DS-5573a | Cycle 1 - Day 1 through Cycle 8 - Day 1 | Pharmacokinetic profile of DS-5573a. \[Time Frame: Cycle 1, 2, 3: Days 1, 2, 4, 8,15; Cycle 4, 5, 6, 7, 8: Day 1\] To assess the pharmacokinetic profile of DS-5573a in Japanese subjects with advanced malignant solid tumors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of human anti-human antibodies (HAHA) against DS-5573a | Cycle 1 - Day 1 through Cycle 1 - Day 15. | Incidence of human anti-human antibodies (HAHA) against DS-5573a. |
| Assessment of tumor response to DS-5573a using RECIST ver1.1. | week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 | Assessment of tumor response is conducted every 6 weeks during the study until study end or the subject discontinues participation. |
| Assessment of DS-5573a-related biomarkers in blood and tumor | Cycle 1 - Days 1,2 through Cycle 3 - Days 1,2 | Assessment of DS-5573a-related biomarkers in blood and tumor. |
Countries
Japan
Outcome results
None listed