Status:
ACTIVE_NOT_RECRUITING
A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Advanced or Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a multicenter, open-label, uncontrolled, phase I study to evaluate the tolerability, safety, pharmacokinetics, and efficacy of ONO-4538HSC administered subcutaneously in participants with adva...
Eligibility Criteria
Inclusion
- Patient with advanced or metastatic solid tumors
- Patients have an ECOG performance status of 0 to 1
- Patients with a life expectancy of at least 3 months
- \[Tolerability confirmation part\]
- Patients who are refractory or intolerant to standard therapy or for whom no standard therapy is available
- \[Expansion part\]
- Patients who are refractory or intolerant to standard therapy, or for whom no standard therapy is available, or for whom monotherapy with intravenous nivolumab is indicated according to the package insert
Exclusion
- Patients with a complication or history of severe hypersensitivity to any antibody product
- Patients with severe complication
Key Trial Info
Start Date :
May 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 29 2028
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT06548217
Start Date
May 7 2024
End Date
February 29 2028
Last Update
July 3 2025
Active Locations (8)
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1
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
2
Tohoku University Hospital
Sendai, Miyagi, Japan
3
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
4
Osaka International Cancer Institute
Osaka, Osaka, Japan