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Clinical Trials in Canada / NCT07360314
Recruiting Phase 1

Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors

NCT07360314 · tracked via the Priya Life Science Canada tracker
Phase
Phase 1
Started
2026-02-13
Last updated
2026-09-09

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

M7437M7437

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Yale University - Yale University School of Medicine New Haven Connecticut Not Yet 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 Canada

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Official registry record

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 Canada