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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

NCT06816108

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