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New smart drug targets tough cancers in first human trial

NCT ID NCT07360314

Disease control Sponsor: EMD Serono Research & Development Institute, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 5 times

Summary

This early-stage trial tests a new drug called M7437 in people with advanced solid tumors that have not responded to standard treatments. M7437 is an antibody-drug conjugate designed to deliver chemotherapy directly to cancer cells that have a specific marker (Ly6E). The study aims to find a safe dose and check for early signs of tumor shrinkage. About 138 participants with cancers like lung, breast, ovarian, head and neck, pancreatic, or stomach cancer will take part.

What this could mean

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

Active substance
M7437 (an antibody-drug conjugate that delivers a chemotherapy drug directly to cancer cells)
What this could lead to
If successful, this could lead to a new treatment option for several advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is a very early (Phase 1) and small study, so the drug may not prove safe or effective. Side effects from the chemotherapy payload 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 138 people

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

Started

Feb 2026

Expected to finish

Mar 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: * Participants have histologically proven advanced solid tumors with known prevalent and high Ly6E expression, Disease characteristic: Participants should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies, or have no standard therapies, or for which no standard therapy is judged appropriate by the Investigator. For each tumor type, participants have received prior lines of therapy, where locally available: * Non-small cell lung cancer (nonsquamous or squamous) * Triple-negative breast cancer * Squamous cell carcinoma of head and neck * Pancreatic ductal adenocarcinoma * Gastric cancer * Epithelial ovarian cancer * Participants with ECOG Performance Status (ECOG) less than and equal to (\<=) 1 * Participants must have blood, liver, and kidney function within safe levels. * Other protocol defined inclusion criteria may apply Exclusion Criteria: * Participant has a history of another malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hyperplasia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years before the date of enrollment). History of hematopoietic allogenic transplantation. * Participants with known brain metastases, except those meeting both of the following criteria: 1. All brain metastases have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment. 2. No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable). * Participants with diarrhea (liquid stool) or ileus Grade more than (\>) 1 within 1 week of Cycle1Day1. * Participants with active chronic inflammatory bowel disease and/or bowel obstruction. * Participants with history of serious gastrointestinal bleeding within 3 months of Cycle1Day1. * Other protocol defined exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

breast neoplasm gastric cancer gastric neoplasm head and neck squamous cell carcinoma non-small cell lung carcinoma ovarian cancer ovarian carcinoma pancreatic ductal adenocarcinoma Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma

As listed by the trial registrant

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

Advanced 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

    9 sites in 4 countries. 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

  • BC Cancer - Vancouver - BC Cancer Agency

    NOT_YET_RECRUITING

    Vancouver, Canada

  • Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • Hospital Universitari Vall d'Hebron - VHIO - Oncology - Phase I Unit

    NOT_YET_RECRUITING

    Barcelona, 08035, Spain

  • NEXT Houston

    RECRUITING

    Galveston, Texas, 77001, United States

  • NEXT Madrid - Hospital Universitario Quironsalud Madrid

    RECRUITING

    Madrid, Spain

  • NEXT Oncology - PARENT

    RECRUITING

    San Antonio, Texas, 78229, United States

  • National Cancer Center Hospital

    RECRUITING

    Tokyo, Japan

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Canada

  • Yale University - Yale University School of Medicine

    NOT_YET_RECRUITING

    New Haven, Connecticut, 06510, United States

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