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A Study of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors
A Study of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors
Active Not RecruitingPhase 1
Sponsor: Ono Pharmaceutical Co., Ltd.
Conditions: Solid Tumor, NSCLC
Interventions: ONO-7428
Countries: Japan
This study is to evaluate the tolerability and safety of ONO-7428 in participants with unresectable advanced or recurrent solid tumors.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
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.
Locations (15)
- Nagoya, Aichi-ken, Japan
- Kashiwa, Chiba, Japan
- Kurume, Fukuoka, Japan
- Nishinomiya, Hyōgo, Japan
- Sagamihara, Kanagawa, Japan
- Yokohama, Kanagawa, Japan
- Nankoku, Kochi, Japan
- Kyoto, Kyoto, Japan
- Hirakata, Osaka, Japan
- Osaka, Osaka, Japan
- Sakai, Osaka, Japan
- Hidaka, Saitama, Japan
- Shinden, Saitama, Japan
- Bunkyō-Ku, Tokyo, Japan
- Koto-Ku, Tokyo, Japan