ONO-7913 Phase I Study (ONO-7913)
Phase 1
Completed
- Conditions
- Solid Tumor
- Registration Number
- NCT04403308
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief Summary
To assess the tolerability, safety, and pharmacokinetics (PK) of ONO-7913 in patients with advanced or metastatic solid cancers and explore its efficacy and biomarkers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
- Patients with histologically or cytologically confirmed advanced or metastatic solid tumors
- ECOG Performance Status of 0-1
- Patients with life expectancy of at least 3 months
Exclusion Criteria
- Patients with multiple cancers
- Patients with history of serious allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Adverse events Up to 24 months Assessed by the NCI CTCAE v5.0 criteria
Dose-limiting toxicities 28 days Number of participants with a DLT
- Secondary Outcome Measures
Name Time Method Concentration vs time of ONO-7913 as single dose Up to 24 months PK profile
Trial Locations
- Locations (1)
Local Institution
🇯🇵Chuo-ku, Tokyo, Japan
Local Institution🇯🇵Chuo-ku, Tokyo, Japan