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

Ono Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Advanced or Metastatic Solid Tumors

Treatments: Drug: ONO-4538HSC

Study type: Interventional

Funder types: Industry

Identifiers

NCT06548217

ONO-4538HSC-01

jRCT2011230059 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 31 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

ONO-4538HSC

Experimental group

Treatment:

Drug: ONO-4538HSC