Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06816108

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nagoya University Hospital, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

ONO-7428

Drug

Specified dose on specified days

Primary outcomes

  1. Dose-limiting toxicities(DLT)

    Time frame: 21 days

  2. Adverse event (AE)

    Time frame: Up to 2 years

Secondary outcomes

  1. Cmax

    Time frame: Up to 2 years

  2. Tmax

    Time frame: Up to 2 years

  3. Area under the Plasma Concentration versus Time Curve (AUC)

    Time frame: Up to 2 years

  4. Ctrough

    Time frame: Up to 2 years

  5. Objective Response Rate (ORR)

    Time frame: Up to 2 years

  6. Disease Control Rate (DCR)

    Time frame: Up to 2 years

  7. Overall Survival (OS)

    Time frame: Up to 2 years

  8. Progression-Free Survival (PFS)

    Time frame: Up to 2 years

  9. Duration of Response (DOR)

    Time frame: Up to 2 years

  10. Time to Response (TTR)

    Time frame: Up to 2 years

  11. Best Overall Response (BOR)

    Time frame: Up to 2 years

  12. Percent change from baseline in the sum of diameters of target lesions

    Time frame: Up to 2 years

  13. Best reduction percent change from baseline in the sum of diameters of target lesions

    Time frame: Up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

International Clinical Trial Support Desk

CONTACT

[email protected]

+17162141777(Standard)

North America Clinical Trial Support Desk

CONTACT

[email protected]

+18665877745(Toll-Free)

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Feb 10, 2025
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.