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

Phase 1

Recruiting

• Conditions: Advanced or Metastatic Solid Tumors
• Interventions: Drug: ONO-4538HSC

• Registration Number: NCT06548217
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-07
• Study First Submitted: 2024-07-29
• Study First Submitted QC: 2024-08-08
• Study First Posted: 2024-08-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Primary Completion: 2028-02-29
• Study Completion: 2028-02-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ONO-4538HSC	ONO-4538HSC	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (8)

Niigata Cancer Center Hospital; 🇯🇵 Niigata-shi, Niigata, Japan

National Cancer Center Hospital East; 🇯🇵 Kashiwa-shi, Chiba, Japan

Tohoku University Hospital; 🇯🇵 Sendai-shi, Miyagi, Japan

Osaka International Cancer Institute; 🇯🇵 Osaka-shi, Osaka, Japan

Kindai University Hospital; 🇯🇵 Osakasayama-shi, Osaka, Japan

Shizuoka Cancer Center; 🇯🇵 Sunto-gun, Shizuoka, Japan

National Cancer Center Hospital; 🇯🇵 Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital Of JFCR; 🇯🇵 Koto-ku, Tokyo, Japan