Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors

June 4, 2025 updated by: Ono Pharmaceutical Co. Ltd

Phase 1 Dose Escalating and Expansion Study of ONO-4578 Given as Monotherapy and Combinations of ONO-4578 and ONO-4538 in Subjects With Advanced or Metastatic Solid Tumors

The objective of the study is to evaluate the safety, tolerability, pharmacokinetics, efficacy and biomarker of ONO-4578 and combinations of ONO-4578 and ONO-4538 in subjects with advanced or metastatic solid tumors and subjects with unresectable, advanced or recurrent gastric cancer, unresectable, advanced or recurrent colorectal cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

183

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan
        • Fukuoka Clinical Site 1
      • Fukuoka, Japan
        • Fukuoka Clinical site 2
      • Osaka, Japan
        • Osaka Clinical Site 1
    • Aichi
      • Nagoya, Aichi, Japan
        • Aichi Clinical Site 1
      • Toyoake, Aichi, Japan
        • Aichi Clinical Site 2
    • Chiba
      • Kashiwa, Chiba, Japan
        • Chiba Clinical Site 1
    • Ehime
      • Matsuyama, Ehime, Japan
        • Ehime Clinical Site1
    • Gunma
      • Ota, Gunma, Japan
        • Gunma Clinical Site 1
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Hokkaido Clinical Site 1
    • Iwate
      • Yahaba-cho, Iwate, Japan
        • Iwate Clinical Site 1
    • Kanagawa
      • Sagamihara, Kanagawa, Japan
        • Kanagawa Clinical Site 2
      • Yokohama, Kanagawa, Japan
        • Kanagawa Clinical Site 1
    • Osaka
      • Hirakata, Osaka, Japan
        • Osaka Clinical site 2
      • Sakai, Osaka, Japan
        • Osaka Clinical site 3
      • Takatsuki, Osaka, Japan
        • Osaka Clinical Site 4
    • Saitama
      • Hidaka, Saitama, Japan
        • Saitama Clinical Site 2
      • Ina-machi, Saitama, Japan
        • Saitama Clinical Site 1
    • Shizuoka
      • Nagaizumi-Cho, Shizuoka, Japan
        • Shizuoka Clinical Site 1
    • Tokyo
      • Chuo-ku, Tokyo, Japan
        • Tokyo Clinical Site 1
      • Itabashi-ku, Tokyo, Japan
        • Tokyo Clinical Site 4
      • Koto-ku, Tokyo, Japan
        • Tokyo Clinical Site 2
      • Shinjyuku-ku, Tokyo, Japan
        • Tokyo Clinical Site 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Advanced or metastatic solid tumors (Part A, B)
  • Unresectable, advanced or recurrent gastric cancer previously treated with anti-PD-(L)1 antibodies or naive to anti-PD-(L)1 antibodies (Part C)
  • Unresectable, advanced or recurrent colorectal cancer(Part D)
  • Life expectancy of at least 3 months
  • Patients with ECOG performance status 0 or 1

Exclusion Criteria:

  • Patients with severe complication
  • Patients with multiple primary cancers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A (Dose Escalation Part): ONO-4578 monotherapy
ONO-4578 specified dose on specified days in advanced or metastatic solid tumors
Drug: ONO-4578
ONO-4578 specified dose on specified days
Experimental: Part B: ONO-4578 in combination with ONO-4538
ONO-4578+ONO-4538 specified dose on specified days in advanced or metastatic solid tumors
Drug: ONO-4578
ONO-4578 specified dose on specified days
Drug: ONO-4538
ONO-4538 specified dose on specified days
Experimental: Part C (Expansion Part): ONO-4578 in combination with ONO-4538
ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent gastric cancer
Drug: ONO-4578
ONO-4578 specified dose on specified days
Drug: ONO-4538
ONO-4538 specified dose on specified days
Experimental: Part D (Expansion Part): ONO-4578 in combination with ONO-4538
ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent colorectal cancer
Drug: ONO-4578
ONO-4578 specified dose on specified days
Drug: ONO-4538
ONO-4538 specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status)
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum observed serum concentration(Cmax)
Time Frame: Up to Cycle 1 (each cycle is 28 days)
Up to Cycle 1 (each cycle is 28 days)
Area Under the blood concentration-time Curve(AUC)
Time Frame: Up to Cycle 1 (each cycle is 28 days)
Up to Cycle 1 (each cycle is 28 days)
Half-life(T1/2) of ONO-4578 both alone and in combination with ONO-4538
Time Frame: Up to Cycle 1 (each cycle is 28 days)
Up to Cycle 1 (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co. Ltd

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2017

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 17, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-4578-01
  • jRCT2080223441 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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