Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
M7437: Participants will receive M7437 at a dose that was determined as recommended dose for expansion (RDE) in Part 1.
Study 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
Primary outcome measure(s)
- 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)
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Yale University - Yale University School of Medicine | New Haven | Connecticut | Recruiting |
| Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center | Huntersville | North Carolina | Recruiting |
| NEXT Houston | Galveston | Texas | Recruiting |
| NEXT Oncology - PARENT | San Antonio | Texas | 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 |
More EMD Serono Research & Development Institute, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07360314 on ClinicalTrials.gov ↗ ← All trials in the USA