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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

Recruiting
18 years and older
All
Phase 1

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Overview

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

Eligibility

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 details
    Solid Tumor
    NSCLC

NCT06816108

Ono Pharmaceutical Co. Ltd

9 May 2025

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