NCT06816108

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
38mo left

Started Apr 2025

Longer than P75 for phase_1

Geographic Reach
1 country

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Apr 2025Jul 2029

First Submitted

Initial submission to the registry

January 29, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 21, 2025

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

4.2 years

First QC Date

January 29, 2025

Last Update Submit

January 9, 2026

Conditions

Solid TumorNSCLC

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicities（DLT）

    21 days

  • Adverse event (AE)

    Up to 2 years

Secondary Outcomes (13)

  • Cmax

    Up to 2 years

  • Tmax

    Up to 2 years

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

    Up to 2 years

  • Ctrough

    Up to 2 years

  • Objective Response Rate (ORR)

    Up to 2 years

  • +8 more secondary outcomes

Study Arms (1)

ONO-7428

EXPERIMENTAL
Drug: ONO-7428

Interventions

ONO-7428DRUG

Specified dose on specified days

ONO-7428

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

RECRUITING

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

RECRUITING

Kurume University Hospital

Kurume, Fukuoka, Japan

RECRUITING

Hyogo Medical University Hospital

Nishinomiya, Hyōgo, Japan

RECRUITING

Kitasato University Hospital

Sagamihara, Kanagawa, Japan

RECRUITING

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

RECRUITING

Kochi Medical School Hospital

Nankoku, Kochi, Japan

RECRUITING

Kyoto University Hospital

Kyoto, Kyoto, 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

Saitama Cancer Center

Shinden, Saitama, Japan

RECRUITING

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyō-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

January 29, 2025

First Posted

February 10, 2025

Study Start

April 21, 2025

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

JP(15)