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New drug ONO-7428 enters first human tests for advanced cancers

NCT ID NCT06816108

Disease control Sponsor: Ono Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times

Summary

This early-phase study tests a new drug called ONO-7428 in about 60 adults with advanced solid tumors that have not responded to standard treatments. The main goal is to see if the drug is safe and tolerable, and to find the right dose. Participants will receive the drug and be monitored for side effects and tumor response.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

35 people

The number who actually took part.

Started

Apr 2025

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NSCLC Solid tumor

Contacts and locations

Locations

  • Hyogo Medical University Hospital

    Nishinomiya, Hyōgo, Japan

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, Japan

  • Kansai Medical University Hospital

    Hirakata, Osaka, Japan

  • Kindai University Hospital

    Sakai, Osaka, Japan

  • Kitasato University Hospital

    Sagamihara, Kanagawa, Japan

  • Kochi Medical School Hospital

    Nankoku, Kochi, Japan

  • Kurume University Hospital

    Kurume, Fukuoka, Japan

  • Kyoto University Hospital

    Kyoto, Kyoto, Japan

  • Nagoya University Hospital

    Nagoya, Aichi-ken, Japan

  • National Cancer Center Hospital East

    Kashiwa, Chiba, Japan

  • Osaka International Cancer Institute

    Osaka, Osaka, Japan

  • Saitama Cancer Center

    Shinden, Saitama, Japan

  • Saitama Medical University International Medical Center

    Hidaka, Saitama, Japan

  • The Cancer Institute Hospital Of JFCR

    Koto-Ku, Tokyo, Japan

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Bunkyō-Ku, Tokyo, Japan

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