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Active Not Recruiting
NCT06816108
A Study of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors
Conditions: Solid Tumor, NSCLC
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 35
Sponsor: Ono Pharmaceutical Co., Ltd.
Location: Nagoya University Hospital Nagoya Aichi-ken
Summary
This study is to evaluate the tolerability and safety of ONO-7428 in participants with unresectable advanced or recurrent solid tumors.
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.
Source: ClinicalTrials.gov (NCT06816108). StuddyBuddy aggregates publicly available trial information.