A Study of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors
NCT ID: NCT06816108
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2025-04-21
2029-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ONO-7428
ONO-7428
Specified dose on specified days
Interventions
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ONO-7428
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
\[Backfill cohort only\] 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
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.
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Project Leader
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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Nagoya University Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Kochi Medical School Hospital
Nankoku, Kochi, Japan
Kyoto University Hospital
Kyoto, Kyoto, Japan
Kansai Medical University Hospital
Hirakata, Osaka, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
Kindai University Hospital
Sakai, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
Saitama Cancer Center
Shinden, Saitama, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō-Ku, Tokyo, Japan
The Cancer Institute Hospital Of JFCR
Koto-Ku, Tokyo, Japan
Countries
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Central Contacts
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Other Identifiers
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ONO-7428-01
Identifier Type: -
Identifier Source: org_study_id
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