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

JRCT ID: jRCT2011230059

Registered date:05/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced or metastatic solid tumors
• Date of first enrollment: 22/04/2024
• Target sample size: 31
• Study type: Interventional
• Intervention(s): ONO-4538HSC will be administered subcutaneously once every 4 weeks.

Outcome(s)

• Primary Outcome: To evaluate the tolerability and safety of ONO-4538HSC administered subcutaneously.
• Secondary Outcome: To evaluate the pharmacokinetics of ONO-4538HSC administered subcutaneously.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

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

Related Information

• Primary Sponsor: Hirashima Yoshinori