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.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me