Description:
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.
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.
Active, not recruiting
Phase 1
Drug | Synonyms | Arms |
---|---|---|
ONO-7913 | ONO-7913 as a Single Agent |
Name | Type | Description | Interventions |
---|---|---|---|
ONO-7913 as a Single Agent | Experimental |
|
Inclusion Criteria: 1. Patients with histologically or cytologically confirmed advanced or metastatic solid tumors 2. ECOG Performance Status of 0-1 3. Patients with life expectancy of at least 3 months Exclusion Criteria: 1. Patients with multiple cancers 2. Patients with history of serious allergy
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Dose-limiting toxicities |
Time Frame: | 28 days |
Safety Issue: | |
Description: | Number of participants with a DLT |
Measure: | Concentration vs time of ONO-7913 as single dose |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | PK profile |
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Ono Pharmaceutical Co. Ltd |
May 10, 2021