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Can a new drug duo shrink Hard-to-Treat tumors?

NCT ID NCT03155061

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This early-stage trial tests an experimental drug called ONO-4578, both on its own and together with another experimental drug, ONO-4538, in people with advanced or metastatic solid tumors. The study also includes separate groups for people with gastric cancer or colorectal cancer that has not responded to standard treatment. Researchers are checking the safety, side effects, and how the drugs move through the body, while also watching for any signs that the tumors shrink.

What this could mean

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

Active substance
ONO-4578, an experimental drug, given alone or combined with another experimental drug, ONO-4538
What this could lead to
If it works, this could lead to a new treatment option for people with advanced solid tumors, including gastric and colorectal cancers.
What could go wrong
This is an early Phase 1 trial, so the main goals are safety and dosing. The drugs may not shrink tumors, and side effects are possible.

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 183 people

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

Started

Apr 2017

Expected to finish

Mar 2028

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

20 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: * Advanced or metastatic solid tumors (Part A, B) * Unresectable, advanced or recurrent gastric cancer previously treated with anti-PD-(L)1 antibodies or naive to anti-PD-(L)1 antibodies (Part C) * Unresectable, advanced or recurrent colorectal cancer(Part D) * Life expectancy of at least 3 months * Patients with ECOG performance status 0 or 1 Exclusion Criteria: * Patients with severe complication * Patients with multiple primary cancers

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Conditions

The condition(s) this trial relates to.

colorectal cancer gastric cancer metastatic malignant neoplasm

As listed by the trial registrant

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

Advanced or metastatic solid tumors

Contacts and locations

Locations

  • Aichi Clinical Site 1

    Nagoya, Aichi-ken, Japan

  • Aichi Clinical Site 2

    Toyoake, Aichi-ken, Japan

  • Chiba Clinical Site 1

    Kashiwa, Chiba, Japan

  • Ehime Clinical Site1

    Matsuyama, Ehime, Japan

  • Fukuoka Clinical Site 1

    Fukuoka, Fukuoka, Japan

  • Fukuoka Clinical Site 2

    Fukuoka, Fukuoka, Japan

  • Gunma Clinical Site 1

    Ōta, Gunma, Japan

  • Hokkaido Clinical Site 1

    Sapporo, Hokkaido, Japan

  • Iwate Clinical Site 1

    Yahaba-cho, Iwate, Japan

  • Kanagawa Clinical Site 1

    Yokohama, Kanagawa, Japan

  • Kanagawa Clinical Site 2

    Sagamihara, Kanagawa, Japan

  • Osaka Clinical Site 1

    Osaka, Osaka, Japan

  • Osaka Clinical Site 2

    Hirakata, Osaka, Japan

  • Osaka Clinical Site 3

    Sakai, Osaka, Japan

  • Osaka Clinical Site 4

    Takatsuki, Osaka, Japan

  • Saitama Clinical Site 1

    Ina-machi, Saitama, Japan

  • Saitama Clinical Site 2

    Hidaka, Saitama, Japan

  • Shizuoka Clinical Site 1

    Nagaizumi-Cho, Shizuoka, Japan

  • Tokyo Clinical Site 1

    Chuo-ku, Tokyo, Japan

  • Tokyo Clinical Site 2

    Koto-ku, Tokyo, Japan

  • Tokyo Clinical Site 3

    Shinjyuku-ku, Tokyo, Japan

  • Tokyo Clinical Site 4

    Itabashi-ku, Tokyo, Japan

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