Trials / Active Not Recruiting
Active Not RecruitingNCT06548217
A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
An Open-label, Uncontrolled, Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- Sponsor
- Ono Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ONO-4538HSC | ONO-4538HSC will be administered subcutaneously once every 4 weeks. |
Timeline
- Start date
- 2024-05-07
- Primary completion
- 2028-02-29
- Completion
- 2028-02-29
- First posted
- 2024-08-12
- Last updated
- 2025-07-03
Locations
8 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT06548217. Inclusion in this directory is not an endorsement.