M7437 (anti-Ly6E exatecan antibody–drug conjugate) for advanced solid tumors with Ly6E expression
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
This trial will test M7437, an antibody–drug conjugate that targets Ly6E and delivers a topoisomerase I inhibitor, to see if it is safe and helps people with advanced solid tumors that express Ly6E.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | EMD Serono Industry-sponsored |
| Locations | 9 sites (New Haven, Connecticut and 8 other locations) |
| Trial ID | NCT07360314 on ClinicalTrials.gov |
What this trial studies
M7437 is an antibody–drug conjugate that links an anti-Ly6E antibody to an exatecan (topoisomerase I inhibitor) payload to deliver chemotherapy directly to Ly6E-expressing tumor cells. This first-in-human, multicenter Phase 1 trial uses dose-escalation cohorts to define safety, tolerability, and pharmacokinetics, with planned expansion cohorts to explore preliminary clinical activity. Eligible adults have unresectable locally advanced or metastatic solid tumors with known Ly6E expression and have typically received prior lines of therapy; participants must have ECOG performance status ≤1 and adequate organ function. The trial is sponsored by EMD Serono in collaboration with Merck KGaA and is enrolling at several U.S. cancer centers.
Who should consider this trial
Good fit: Adults with unresectable locally advanced or metastatic solid tumors known to express Ly6E who are refractory to or lack standard therapies, with ECOG ≤1 and adequate blood, liver, and kidney function are the intended participants.
Not a fit: Patients whose tumors lack Ly6E expression, those with ECOG >1, or those with significant organ dysfunction or recent other malignancies are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, M7437 could shrink tumors or slow disease progression in patients whose cancers express Ly6E by delivering a potent chemotherapy directly to cancer cells.
How similar studies have performed: Other antibody–drug conjugates using exatecan/DXd or topoisomerase I inhibitor payloads have shown promising activity in certain cancers, but targeting Ly6E with M7437 is a novel, first-in-human approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Haven, Connecticut and 8 other locations
- 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 (Not_yet_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 (Not_yet_recruiting)
Study contacts
- Study coordinator: US Medical Information
- Email: eMediUSA@emdserono.com
- Phone: 888-275-7376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.