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New drug combo tested for tough-to-treat cancers

NCT ID NCT05423262

Disease control Sponsor: Toray Industries, Inc 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called TRK-950 in people with advanced solid tumors or melanoma that has not responded to standard treatments. The first parts check safety and side effects when given alone or with another cancer drug (nivolumab). The final part looks at whether TRK-950 can shrink tumors in people with advanced melanoma. About 49 participants will be enrolled.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 49 people

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

Started

Jul 2022

Expected to finish

Dec 2027

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: * Part 1: Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who have been refractory or intolerant to standard therapies or for whom no standard therapy exists. Part 2: Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who are eligible for standard therapy with NIVO 240 mg alone administered at 2-week intervals. * Part 3: Patients with histologically confirmed locally advanced unresectable or metastatic melanoma (excluding uveal melanoma), who received prior chemotherapy with DTIC and for whom no standard therapy exists * Patients with life expectancy of at least 3 months after the start of study drug administration * Patients aged \>=18 years at the time of consent * Patients who are able to provide written consent in person to be a subject of this study * A negative pregnancy test before enrollment (if female of childbearing potential) Exclusion Criteria: * Patients with active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy * Pregnant women (including those who are considered possibly pregnant based on history taking, etc. by physician) or breastfeeding women (interrupting breastfeeding to enroll is also not allowed) * Patients who are unwilling or unable to comply with the protocol specified procedures * Patients who are positive for human immunodeficiency virus (HIV) antibody * Patients who meet any of the following conditions on hepatitis B virus (HBV) and hepatitis C virus (HCV) testing * Patients who are positive for hepatitis B surface antigen (HBsAg) * Patients who are positive for HCV RNA

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Conditions

The condition(s) this trial relates to.

melanoma neoplasm

As listed by the trial registrant

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

Melanoma Solid tumor

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

  • Keio University Hospital

    RECRUITING

    Shinjuku-Ku, Tokyo, 160-8582, Japan

  • Kumamoto University Hospital

    RECRUITING

    Kumamoto, Kumamoto, 860-8556, Japan

  • Nagoya City University Hospital

    RECRUITING

    Nagoya, Aichi-ken, 467-8602, Japan

  • National Cancer Center Hospital

    RECRUITING

    Chuo Ku, Tokyo, 104-0045, Japan

  • National Hospital Organization Kyushu Cancer Center

    RECRUITING

    Fukuoka, Fukuoka, 811-1395, Japan

  • Niigata Cancer Center Hospital

    RECRUITING

    Niigata, Niigata, 951-8566, Japan

  • Saitama Medical University International Medical Center

    RECRUITING

    Hidaka, Saitama, 350-1298, Japan

  • Sapporo Medical University Hospital

    RECRUITING

    Sapporo, Hokkaido, 060-8543, Japan

  • Shinshu University Hospital

    RECRUITING

    Matsumoto, Nagano, 390-8621, Japan

  • Shizuoka Cancer Center

    RECRUITING

    Nagaizumi-chō, Shizuoka, 411-8777, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.