Experimental biologic M1-c6v1 put to the test in Hard-to-Treat solid tumors

NCT ID NCT06046742

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing an experimental intravenous biologic called M1-c6v1 in adults with locally advanced or metastatic solid tumors that have not responded to standard treatment. The Phase I trial gives escalating doses to a small group of participants to check safety, find the highest dose people can tolerate, and measure how the body handles the drug. Participants receive M1-c6v1 by intravenous drip, and researchers track side effects and dose-limiting toxicities to decide a dose for future studies.

What this could mean

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

Active substance
an experimental intravenous biologic called M1-c6v1
What this could lead to
If it works, this could point toward a new treatment option for people whose advanced solid tumors have stopped responding to standard therapy.
What could go wrong
This is a first-in-human Phase I trial with about 12 participants, so its main goal is checking safety and dosing, not proving the drug works. Most early-stage cancer drugs do not make it to later trials, and intravenous biologics can cause immune reactions or other side effects.

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 12 people

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

Started

Jul 2024

Expected to finish

Dec 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

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. Subjects must have diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy. 2. Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures. 3. Males and females at least 18 years of age, inclusive, at the Screening Visit. 4. Have at least one measurable lesion. 5. An Eastern Cooperative Oncology Group (ECOG) score of 0-1, 1 week before the first administration of IMP. 6. An estimated survival time of ≥ 12 weeks. Exclusion Criteria: 1. Subject has a history of primary or acquired immunodeficient states, leukemia, lymphoma, acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy. 2. Subject has received any anti-tumor treatment 4 weeks before using the IMP, including chemotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy. 3. Subject has received systemic glucocorticoids (prednisone \>10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days prior to first administration of IMP. 4. Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa-shi, Chiba, Japan

    Contact Email: •••••@•••••

  • National Hospital Organization Shikoku Cancer Center

    RECRUITING

    Matsuyama, Ehime, Japan

    Contact Email: •••••@•••••

  • St. Marianna University Hospital

    RECRUITING

    Kawasaki-shi, Kanagawa, Japan

    Contact Email: •••••@•••••

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