ONO-4538HSC-01:A phase I study of ONO-4538HSC in subjects with advanced or metastatic solid tumors

ONO-4538HSC-01:An open-label, uncontrolled, phase I study of ONO-4538HSC in subjects with advanced or metastatic solid tumors

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2011230059

Enrollment

Registered

2024-03-05

Start date

2024-05-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or metastatic solid tumors

Interventions

ONO-4538HSC will be administered subcutaneously once every 4 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patient with advanced or metastatic solid tumors 2.Patients have an ECOG performance status of 0 to 1 3.Patients with a life expectancy of at least 3 months [Tolerability confirmation part] 4.Patients who are refractory or intolerant to standard therapy or for whom no standard therapy is available [Expansion part] 5.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 criteria

Exclusion criteria: 1.Patients with a complication or history of severe hypersensitivity to any antibody product 2.Patients with severe complication

Design outcomes

Primary

Measure	Time frame
To evaluate the tolerability and safety of ONO-4538HSC administered subcutaneously.	—

Secondary

Measure	Time frame
To evaluate the pharmacokinetics of ONO-4538HSC administered subcutaneously.	—

Contacts

Public ContactSupport Desk JP

Ono Pharmaceutical Co.,LTD

clinical_trial@ono-pharma.com+81-120-278-120

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026