RecruitingPhase 1NCT07360314

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

Sponsor

EMD Serono Research & Development Institute, Inc.

Enrollment

138 participants

Start Date

Feb 13, 2026

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumors

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new antibody-drug conjugate called M7437 that targets a protein called Ly6E, which is found on certain solid tumors. It is an early-phase trial for people with advanced cancers that no longer respond to standard treatments. **You may be eligible if...** - You have advanced (unresectable or metastatic) cancer of the following types: non-small cell lung cancer, triple-negative breast cancer, head and neck squamous cell cancer, pancreatic cancer, gastric cancer, or epithelial ovarian cancer - Your cancer has progressed after standard therapies - You are well enough to carry out daily activities (ECOG 0–1) - Your blood, liver, and kidney function are within acceptable limits **You may NOT be eligible if...** - You have had another cancer diagnosis in the past 3 years (with certain exceptions such as treated skin cancers) - You have active or unstable brain metastases - You have had an allogenic stem cell or bone marrow transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGM7437

Participants will receive M7437 as an intravenous infusion at a dose corresponding to their assigned cohort. Dose escalation will occur between cohorts, with 3-4 participants enrolled at each dose level before proceeding to the next higher dose.

DRUGM7437

Participants will receive M7437 at a dose that was determined as recommended dose for expansion (RDE) in Part 1.