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Clinical Trials in Japan / NCT06816108
Active, not recruiting Phase 1

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

NCT06816108 · tracked via the Priya Life Science Japan tracker
Phase
Phase 1
Started
2025-04-21
Last updated
2026-08-05

Condition(s) studied

Solid TumorNSCLC

Investigational drug(s) / intervention(s)

ONO-7428

ONO-7428: Specified dose on specified days

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Nagoya University Hospital Nagoya Aichi-ken
National Cancer Center Hospital East Kashiwa Chiba
Kurume University Hospital Kurume Fukuoka
Hyogo Medical University Hospital Nishinomiya Hyōgo
Kitasato University Hospital Sagamihara Kanagawa
Kanagawa Cancer Center Yokohama Kanagawa
Kochi Medical School Hospital Nankoku Kochi
Kyoto University Hospital Kyoto Kyoto
Kansai Medical University Hospital Hirakata Osaka
Osaka International Cancer Institute Osaka Osaka
Kindai University Hospital Sakai Osaka
Saitama Medical University International Medical Center Hidaka Saitama
Saitama Cancer Center Shinden Saitama
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Bunkyō-Ku Tokyo
The Cancer Institute Hospital Of JFCR Koto-Ku Tokyo

More Ono Pharmaceutical Co., Ltd. trials in Japan

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06816108 on ClinicalTrials.gov ↗ ← All trials in Japan