Clinical Trial

A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors

Active, Not Recruiting Phase 1
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-08-08; most recent amendment 2025-07-01.
Status change: Recruiting → Active, Not Recruiting 2025-07-01
Trial Details
NCT Number NCT06548217
Lead Sponsor Ono Pharmaceutical Co., Ltd.
Conditions Advanced or Metastatic Solid Tumors
Enrollment 31 participants
Start Date 2024-05-07
Primary Completion 2028-02-29 (estimated)
Study Completion 2028-02-29 (estimated)
Updated on ClinicalTrials.gov 2025-07-03