Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors
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).
Conditions studied
Advanced Solid Tumors
About this study
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).
Interventions
- Drug: M7437 — 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.
- Drug: M7437 — Participants will receive M7437 at a dose that was determined as recommended dose for expansion (RDE) in Part 1.
Primary outcomes
- Dose-escalation Cohort: Occurences of Dose Limiting Toxicities (DLTs) (DLT period is 21 days (cycle 1))
- Dose-escalation Cohort: Number of Participants With Treatment-Emergent Adverse Event (TEAEs) and Adverse Event (AEs) (Up to end of Part 1 of study (approximately 1 year 8 months))
Eligibility information
Study locations
- Yale University - Yale University School of Medicine, New Haven, Connecticut 06510 United States
- Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center, Huntersville, North Carolina 28078 United States
- NEXT Houston, Galveston, Texas 77001 United States
- NEXT Oncology - PARENT, San Antonio, Texas 78229 United States
- Princess Margaret Cancer Centre, Toronto, Canada
- BC Cancer - Vancouver - BC Cancer Agency, Vancouver, Canada
- National Cancer Center Hospital, Tokyo, Japan
- Hospital Universitari Vall d'Hebron - VHIO - Oncology - Phase I Unit, Barcelona, 08035 Spain
- NEXT Madrid - Hospital Universitario Quironsalud Madrid, Madrid, Spain
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.