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RecruitingPhase 1NCT06816108

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

A Phase I, Open-label, Dose Escalation Study to Evaluate the Tolerability and Safety of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors

Sponsor

Ono Pharmaceutical Co., Ltd.

Enrollment

60 participants

Start Date

Apr 21, 2025

Study Type

INTERVENTIONAL

Conditions

NSCLCSolid Tumor

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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.
  • Participants who are refractory or intolerant to standard therapy.
  • 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.
  • Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1.
  • Participants with tumor tissue samples available for biomarker testing.

Exclusion Criteria6

  • Participants with a complication or history of severe hypersensitivity to any other antibody drugs.
  • Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
  • Participants with severe peritoneal dissemination.
  • Participants with pericardial fluid, pleural effusion, or ascites requiring treatment.
  • Participants with uncontrolled tumor-related pain.
  • Participants with active or history of interstitial lung disease or pulmonary fibrosis.

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Interventions

DRUGONO-7428

Specified dose on specified days

Locations(15)

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

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NCT06816108

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