Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors
United States, Canada, Japan138 participantsStarted 2026-02-13
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on finding a safe dose of M7437, what does that mean for what we currently know — or don't know — about its safety and effectiveness in people?
2The trial is measuring something called 'dose-limiting toxicities' — can you explain what kinds of side effects they're watching for with this drug, and how that might affect my day-to-day life if I were to participate?
3M7437 targets something called Ly6E — do my tumor results suggest that this target is relevant to my specific cancer, and does that affect whether this trial might even be worth considering for me?
4Given that this is an early-phase study in advanced solid tumors broadly, would standard treatment options still be available to me if I tried this trial and it didn't work out?
5This trial is currently recruiting — what would the time commitment and visit schedule realistically look like for me, and is that something my situation could support?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose-escalation Cohort: Occurences of Dose Limiting Toxicities (DLTs)
Timeframe: DLT period is 21 days (cycle 1)
2
Dose-escalation Cohort: Number of Participants With Treatment-Emergent Adverse Event (TEAEs) and Adverse Event (AEs)
Timeframe: Up to end of Part 1 of study (approximately 1 year 8 months)
Trial details
NCT IDNCT07360314
SponsorEMD Serono Research & Development Institute, Inc.