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NCT07360314RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 20 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
138 (estimated)
First submitted
13 Jan 2026
Start date
13 Feb 2026
Primary completion date
28 Sept 2028
Lead sponsor
EMD Serono Research & Development Institute, Inc.
NCT number
NCT07360314
EU CT number
2025-523232-39-00

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 138
  • From 13 Feb 2026 to the primary completion date, 28 Sept 2028
  • 9 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants with known brain metastases, except those meeting both of the following criteria:
    • All brain metastases have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment.
    • 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).

Other illness

  • 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 active chronic inflammatory bowel disease and/or bowel obstruction.
  • Participants with history of serious gastrointestinal bleeding within 3 months of Cycle1Day1.

Other

  • Participants with diarrhea (liquid stool) or ileus Grade more than (\>) 1 within 1 week of Cycle1Day1.
  • Other protocol defined exclusion criteria may apply.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Princess Margaret Cancer Centre
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
BC Cancer - Vancouver - BC Cancer Agency
Coordinator of this site? Confirm its status
VancouverCanadaNot yet recruiting
Hospital Universitari Vall d'Hebron - VHIO - Oncology - Phase I Unit
Coordinator of this site? Confirm its status
BarcelonaSpainNot yet recruiting
NEXT Madrid - Hospital Universitario Quironsalud Madrid
Coordinator of this site? Confirm its status
MadridSpainRecruiting
National Cancer Center Hospital
Coordinator of this site? Confirm its status
TokyoJapanRecruiting
NEXT Houston
Coordinator of this site? Confirm its status
GalvestonUnited StatesRecruiting
Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center
Coordinator of this site? Confirm its status
HuntersvilleUnited StatesRecruiting
Yale University - Yale University School of Medicine
Coordinator of this site? Confirm its status
New HavenUnited StatesRecruiting
NEXT Oncology - PARENT
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.