drugset / Trial / NCT06548217

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

NCT06548217 ↗

Phase 1 Active not recruiting 31 enrolled Ono Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-05-07
Primary completion
2028-02-29
Completion
2028-02-29

Drugs

EvaluationDrugModalityDoseRoute
Subject ONO-4538HSC Unknown — Subcutaneous

Indications

No indication recorded.