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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced or Metastatic Solid Tumors
• Intervention / Treatment: Drug: ONO-4538HSC

• Study Type: Interventional
• Enrollment (Estimated): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Chiba
    • Kashiwa-shi, Chiba, Japan
      • National Cancer Center Hospital East
  • Miyagi
    • Sendai-shi, Miyagi, Japan
      • Tohoku University Hospital
  • Niigata
    • Niigata-shi, Niigata, Japan
      • Niigata Cancer Center Hospital
  • Osaka
    • Osaka-shi, Osaka, Japan
      • Osaka International Cancer Institute
    • Osakasayama-shi, Osaka, Japan
      • Kindai University Hospital
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan
      • Shizuoka Cancer Center
  • Tokyo
    • Chuo-ku, Tokyo, Japan
      • National Cancer Center Hospital
    • Koto-ku, Tokyo, Japan
      • The Cancer Institute Hospital Of JFCR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ONO-4538HSC	Drug: ONO-4538HSC; ONO-4538HSC will be administered subcutaneously once every 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose-limiting toxicities (DLT)	28 days
Adverse event (AE)	UP to 100 days after the last dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics（serum concentration of Nivolumab）	Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)

Other Outcome Measures

Outcome Measure	Time Frame
Overall response rate (ORR)	Through study completion, an average of 6 months
Disease control rate (DCR)	Through study completion, an average of 6 months
Overall survival (OS)	Through study completion, an average of 6 months
Progression-free survival (PFS)	Through study completion, an average of 6 months
Duration of response (DOR)	Through study completion, an average of 6 months
Time to response (TTR)	Through study completion, an average of 6 months
Best overall response (BOR)	Through study completion, an average of 6 months
Percentage of change in the sum of tumor diameters of target lesions	Through study completion, an average of 6 months
Maximum percent change in the sum diameters of the target lesions	Through study completion, an average of 6 months
Anti-Nivolumab antibody	Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)
Anti-rHuPH20 antibody	Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2024
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 29, 2028

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Nivolumab
• Other Study ID Numbers: ONO-4538HSC-01; jRCT2011230059 (Registry Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No