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

NCT06548217 | Active Not Recruiting Phase 1 DMC

• 2 other identifiers: ONO-4538HSC-01jRCT2011230059
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 8

Brief 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

Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicities (DLT)

  28 days

• Adverse event (AE)

  UP to 100 days after the last dose

Secondary Outcomes (1)

• 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 Outcomes (11)

• 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

Study Arms (1)

ONO-4538HSC

EXPERIMENTAL

Drug: ONO-4538HSC

Interventions

ONO-4538HSC DRUG

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

ONO-4538HSC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with a complication or history of severe hypersensitivity to any antibody product
• Patients with severe complication

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (8)

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, Japan

Location

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Location

Osaka International Cancer Institute

Osaka, Osaka, Japan

Location

Kindai University Hospital

Osakasayama-shi, Osaka, Japan

Location

Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Location

The Cancer Institute Hospital Of JFCR

Koto-ku, Tokyo, Japan

Location

Study Officials

• Project Leader

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 12, 2024
• Study Start: May 7, 2024
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 29, 2028
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (8)