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NCT Number: NCT07787208

A Study of ONO-7429 in Participants With Unresectable Advanced or Recurrent Solid Tumors

This study is to evaluate the tolerability and safety of ONO-7429 in participants with unresectable advanced or recurrent solid tumors.

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center Hospital East, Kashiwa, Chiba, 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.
  • Participants who are refractory or intolerant to standard therapy.
  • 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 history or presence of severe hypersensitivity to any other antibody agents.
  • Participants with pericardial fluid, pleural effusion or ascites requiring treatment
  • Participants with uncontrolled tumor-related pain
  • Participants with severe peritoneal dissemination.
  • Participants with multiple primary cancers.
  • Participants with a history or presence of ILD or pulmonary fibrosis.

Treatment and study plan

ONO-7429

Drug

Specified dose on specified days

Primary outcomes

  1. Dose-limiting toxicities（DLT）

    Time frame: From first dose through completion of the DLT evaluation period (approximately 21 days)

  2. Adverse event (AE)

    Time frame: Approximately 6 months

Secondary outcomes

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

    Time frame: Approximately 6 months

  2. Cmax

    Time frame: Approximately 6 months

  3. Tmax

    Time frame: Approximately 6 months

  4. Terminal elimination half-life（T1/2）

    Time frame: Approximately 6 months

  5. Ctrough

    Time frame: Approximately 6 months

  6. CL

    Time frame: Approximately 6 months

  7. Volume of distribution at steady state（Vss）

    Time frame: Approximately 6 months

  8. Objective Response Rate (ORR)

    Time frame: Approximately 6 months

  9. Disease Control Rate (DCR)

    Time frame: Approximately 6 months

  10. Best overall response（BOR）

    Time frame: Approximately 6 months

  11. Duration of Response (DOR)

    Time frame: Approximately 6 months

  12. Progression-Free Survival (PFS)

    Time frame: Approximately 6 months

  13. Overall Survival (OS)

    Time frame: Approximately 6 months

  14. Time to Response (TTR)

    Time frame: Approximately 6 months

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

    Time frame: Approximately 6 months

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

    Time frame: Approximately 6 months

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase 1, Open-label, Dose Escalation Study to Investigate the Safety and Tolerability of ONO-7429 in Participants With Unresectable Advanced or Recurrent Solid Tumors

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Aug 26, 2026
Registry last updated
Aug 26, 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.

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