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NCT07360314From ClinicalTrials.govRecruiting

Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors

A Phase 1, 2-Part, Multicenter, Open-Label, First-in-Human Study of the Anti-Ly6E Exatecan Antibody-Drug Conjugate M7437 in Participants With Advanced Solid Tumors

  • Advanced Solid Tumors

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
EMD Serono Research & Development Institute, Inc.
Enrolment target
138
Started
13 February 2026
Main results due
28 September 2028
Study sites
9
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary clinical activity of M7437 in participants with locally advanced or metastatic solid tumors with known Ly6E expression, including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), epithelial ovarian carcinoma (EOC), squamous cell carcinoma of the head and neck (SCCHN), pancreatic ductal adenocarcinoma (PDAC), and gastric cancer (GC).

Study sites(9)

  • Yale University - Yale University School of Medicine

    New Haven, Connecticut, United States

    Not yet recruiting

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

    Huntersville, North Carolina, United States

    Recruiting

  • NEXT Houston

    Galveston, Texas, United States

    Recruiting

  • NEXT Oncology - PARENT

    San Antonio, Texas, United States

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Canada

    Recruiting

  • BC Cancer - Vancouver - BC Cancer Agency

    Vancouver, Canada

    Not yet recruiting

  • National Cancer Center Hospital

    Tokyo, Japan

    Recruiting

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

    Barcelona, Spain

    Not yet recruiting

  • NEXT Madrid - Hospital Universitario Quironsalud Madrid

    Madrid, Spain

    Recruiting

Showing 9 of 9 sites. 6 of the 9 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07360314. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors | Trialion