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

Phase 1

Recruiting

• Conditions: NSCLC; Solid Tumor
• Interventions: Drug: ONO-7428

• Registration Number: NCT06816108
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-02-04
• Study First Posted: 2025-02-10
• Study Start: 2025-04-21
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-01
• Last Update Posted: 2025-06-03
• Primary Completion: 2029-07
• Study Completion: 2029-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ONO-7428	ONO-7428	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicities（DLT）	21 days
Adverse event (AE)	Up to 2 years

Secondary Outcome Measures

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

Trial Locations

Locations (3)

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

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

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