ONO-4538 Phase I Study in Patients With Solid Tumor
Study Details
Study Description
Brief Summary
The objective of the study is to investigate the pharmacokinetics of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: ONO-4538 1mg/kg ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, single dose |
Drug: ONO-4538
|
Experimental: ONO-4538 3mg/kg ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, single dose |
Drug: ONO-4538
|
Experimental: ONO-4538 10mg/kg ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, single dose |
Drug: ONO-4538
|
Outcome Measures
Primary Outcome Measures
- PK outcome: Cmax of ONO-4538 [Approximately 3 weeks]
- PK outcome: Tmax of ONO-4538 [Approximately 3 weeks]
Secondary Outcome Measures
- Safety outcome: The number of subjects with overall adverse events [Approximately 3 weeks]
- Safety outcome: The number of deaths [Approximately 3 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female ≥ 20 years of age
-
Histologically or cytologically confirmed solid tumor
-
Patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available
-
ECOG Performance Status is 0 to 1
Exclusion Criteria:
-
Current or prior severe hypersensitivity to another antibody product
-
Multiple primary cancers
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Seongnam-si Clinical Site 105 | Seongnam-si | Gyeonggi-do | Korea, Republic of | |
2 | Seoul Clinical Site 101 | Seoul | Korea, Republic of | ||
3 | Seoul Clinical Site 102 | Seoul | Korea, Republic of | ||
4 | Seoul Clinical Site 103 | Seoul | Korea, Republic of | ||
5 | Seoul Clinical Site 104 | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Ono Pharmaceutical Co. Ltd
Investigators
- Study Director: Mitsunobu Tanimoto, Ono Pharmaceutical Co. Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ONO-4538-13