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A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
Sponsor: Ono Pharmaceutical Co. Ltd
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 advanced or metastatic solid tumors. This study consists of the tolerability confirmation part to determine the recommended dose for Japanese participants by evaluating the DLTs and the expansion part to evaluate the safety and pharmacokinetics and to explore the efficacy.
Official title: An Open-label, Uncontrolled, Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2024-05-07
Completion Date
2028-02-29
Last Updated
2025-07-03
Healthy Volunteers
No
Conditions
Interventions
ONO-4538HSC
ONO-4538HSC will be administered subcutaneously once every 4 weeks.
Locations (8)
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital Of JFCR
Koto-ku, Tokyo, Japan