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Can a new drug tame tumors that resist standard therapy?

NCT ID NCT07787208

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing an experimental drug called ONO-7429 in about 80 people with advanced or recurrent solid tumors that have not responded to or cannot tolerate standard treatments. The main goal is to find out whether the drug is safe and tolerable, and to determine the right dose. Researchers will also watch for signs that the drug may help control the disease, such as tumor shrinkage or slowing of growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ONO-7429, an experimental drug given by specified doses on specified days
What this could lead to
If ONO-7429 proves safe and tolerable, it could become a new treatment option for people with advanced solid tumors who have run out of standard options.
What could go wrong
This is an early, small phase 1 trial focused on safety and dosing, so it is unknown whether ONO-7429 will effectively shrink tumors or control the disease. There may be side effects, and the drug may not work as hoped.

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

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Mar 2030

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. 2. Participants who are refractory or intolerant to standard therapy. 3. Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1. 4. Participants with tumor tissue samples available for biomarker testing. Exclusion Criteria: 1. Participants with a history or presence of severe hypersensitivity to any other antibody agents. 2. Participants with pericardial fluid, pleural effusion or ascites requiring treatment 3. Participants with uncontrolled tumor-related pain 4. Participants with severe peritoneal dissemination. 5. Participants with multiple primary cancers. 6. Participants with a history or presence of ILD or pulmonary fibrosis.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Gunma University Hospital

    RECRUITING

    Maebashi, Gunma, Japan

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata, Osaka, Japan

  • Kindai University Hospital

    RECRUITING

    Sakai, Osaka, Japan

  • National Cancer Center Hospital

    RECRUITING

    Chuo-ku, Tokyo, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Chiba, Japan

  • Niigata Cancer Center Hospital

    RECRUITING

    Niigata, Niigata, Japan

  • Osaka International Cancer Institute

    RECRUITING

    Osaka, Osaka, Japan

  • Saitama Medical University International Medical Center

    RECRUITING

    Hidaka, Saitama, Japan

  • Shizuoka Cancer Center

    RECRUITING

    Sunto-gun, Shizuoka, Japan

  • The Cancer Institute Hospital of JFCR

    RECRUITING

    Koto-ku, Tokyo, Japan

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