A Study of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors

A Phase I, Open-label, Dose Escalation Study to Evaluate the Tolerability and Safety of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors

This study is to evaluate the tolerability and safety of ONO-7428 in participants with unresectable advanced or recurrent solid tumors.

Study Overview

• Status: Recruiting
• Conditions: NSCLC; Solid Tumor
• Intervention / Treatment: Drug: ONO-7428

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: North America Clinical Trial Support Desk; Phone Number: +18665877745(Toll-Free); Email: clinical_trial@ono-pharma.com
• Study Contact Backup: Name: International Clinical Trial Support Desk; Phone Number: +17162141777(Standard); Email: clinical_trial@ono-pharma.com

Study Locations

• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan
      • Recruiting
      • Nagoya University Hospital
  • Chiba
    • Kashiwa, Chiba, Japan
      • Recruiting
      • National Cancer Center Hospital East
  • Fukuoka
    • Kurume, Fukuoka, Japan
      • Recruiting
      • Kurume University Hospital
  • Hyōgo
    • Nishinomiya, Hyōgo, Japan
      • Recruiting
      • Hyogo Medical University Hospital
  • Kanagawa
    • Sagamihara, Kanagawa, Japan
      • Recruiting
      • Kitasato University Hospital
    • Yokohama, Kanagawa, Japan
      • Recruiting
      • Kanagawa Cancer Center
  • Kochi
    • Nankoku, Kochi, Japan
      • Recruiting
      • Kochi Medical School Hospital
  • Kyoto
    • Kyoto, Kyoto, Japan
      • Recruiting
      • Kyoto University Hospital
  • Osaka
    • Hirakata, Osaka, Japan
      • Recruiting
      • Kansai Medical University Hospital
    • Osaka, Osaka, Japan
      • Recruiting
      • Osaka International Cancer Institute
    • Sakai, Osaka, Japan
      • Recruiting
      • Kindai University Hospital
  • Saitama
    • Hidaka, Saitama, Japan
      • Recruiting
      • Saitama Medical University International Medical Center
    • Shinden, Saitama, Japan
      • Recruiting
      • Saitama Cancer Center
  • Tokyo
    • Bunkyō-Ku, Tokyo, Japan
      • Recruiting
      • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
    • Koto-Ku, Tokyo, Japan
      • Recruiting
      • 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. Participants with histologically or cytologically confirmed unresectable advanced or recurrent solid tumors.

   [Backfill cohort only] Participants with histologically or cytologically confirmed Stage IIIB, IIIC, IV, or recurrent NSCLC according to UICC-TNM classification.

2. Participants who are refractory or intolerant to standard therapy.
3. Participants with a tumor type for which anti-PD-(L)1 antibodies have been approved and who have previously treated with anti-PD-(L)1 antibody containing regimen.
4. Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1.
5. Participants with tumor tissue samples available for biomarker testing.

Exclusion Criteria:

1. Participants with a complication or history of severe hypersensitivity to any other antibody drugs.
2. Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
3. Participants with severe peritoneal dissemination.
4. Participants with pericardial fluid, pleural effusion, or ascites requiring treatment.
5. Participants with uncontrolled tumor-related pain.
6. Participants with active or history of interstitial lung disease or pulmonary fibrosis.

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-7428	Drug: ONO-7428; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose-limiting toxicities（DLT）	21 days
Adverse event (AE)	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	Up to 2 years
Disease Control Rate (DCR)	Up to 2 years
Duration of Response (DOR)	Up to 2 years
Objective Response Rate (ORR)	Up to 2 years
Progression-Free Survival (PFS)	Up to 2 years
Cmax	Up to 2 years
Tmax	Up to 2 years
Area under the Plasma Concentration versus Time Curve (AUC)	Up to 2 years
Ctrough	Up to 2 years
Time to Response (TTR)	Up to 2 years
Best Overall Response (BOR)	Up to 2 years
Percent change from baseline in the sum of diameters of target lesions	Up to 2 years
Best reduction percent change from baseline in the sum of diameters of target lesions	Up to 2 years

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): April 21, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ONO-7428-01

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