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

NCT07787208 | Recruiting Phase 1

• 1 other identifier: ONO-7429-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicities（DLT）

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

• Adverse event (AE)

  Approximately 6 months

Secondary Outcomes (16)

• Area under the Plasma Concentration versus Time Curve (AUC)

  Approximately 6 months

• Cmax

  Approximately 6 months

• Tmax

  Approximately 6 months

• Terminal elimination half-life（T1/2）

  Approximately 6 months

• Ctrough

  Approximately 6 months

Study Arms (1)

ONO-7429

EXPERIMENTAL

Drug: ONO-7429

Interventions

ONO-7429 DRUG

Specified dose on specified days

ONO-7429

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ono Pharmaceutical Co., Ltd.: lead

Study Sites (10)

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

RECRUITING

Gunma University Hospital

Maebashi, Gunma, Japan

RECRUITING

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

RECRUITING

Kansai Medical University Hospital

Hirakata, Osaka, Japan

RECRUITING

Osaka International Cancer Institute

Osaka, Osaka, Japan

RECRUITING

Kindai University Hospital

Sakai, Osaka, Japan

RECRUITING

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

RECRUITING

Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

RECRUITING

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

RECRUITING

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

RECRUITING

Study Officials

• Project Leader

  Ono Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

North America Clinical Trial Support Desk

CONTACT

+18665877745(Toll-Free); clinical_trial@ono-pharma.com

International Clinical Trial Support Desk

CONTACT

+17162141777(Standard); clinical_trial@ono-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 26, 2026
• Study Start: June 19, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): March 1, 2030
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (10)