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Taking people in SpainPhase 1

Tests M7437 in adults with advanced solid tumors that have Ly6E

Tests the drug M7437 in adults with advanced solid tumors that express Ly6E.

Key facts

Who runs it
EMD Serono Research & Development Institute, Inc.
Where
Barcelona and Madrid, SpainSee the 2 sitesAlso in 3 other countries, 7 sites
Trial code
Registry title
Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors
Status
Recruiting
Phase
Phase 1
People taking part
138 people, planned
Started
13 Feb 2026
Expected to end
28 Mar 2029
Type of study
Interventional, 2 groups
Treatments tested
  • M7437
Record updated
20 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced solid tumors that have high Ly6E expression and have not responded to standard treatment, or have no standard treatment. It tests a new drug called M7437.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Advanced solid tumor that cannot be removed by surgery, locally advanced or spread to other parts of the body, with known high Ly6E expression. Tumor types named: non-small cell lung cancer, triple-negative breast cancer, head and neck squamous cell cancer, pancreatic ductal adenocarcinoma, gastric cancer, epithelial ovarian cancer.
Earlier treatment
The tumor did not respond to standard therapies, or there is no standard therapy, or the Investigator judges no standard therapy appropriate. For each tumor type, people have had prior lines of therapy, where locally available.
Biomarker or test result
Known prevalent and high Ly6E expression in the tumor. ECOG performance status of 1 or lower. Blood, liver and kidney function within safe levels.

Main reasons for not taking part

  • Another cancer within the last 3 years (some exceptions apply)
  • Past hematopoietic allogenic transplantation
  • Known brain metastases, unless treated and stable for at least 4 weeks with no related symptoms
  • Diarrhea or ileus above Grade 1 within 1 week of Cycle 1 Day 1
  • Active chronic inflammatory bowel disease or bowel obstruction

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Participants with known brain metastases, except those meeting both of the following 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)
  • 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 active chronic inflammatory bowel disease and/or bowel obstruction
  • Participants with history of serious gastrointestinal bleeding within 3 months of Cycle1Day1
  • Participants with diarrhea (liquid stool) or ileus Grade more than (>) 1 within 1 week of Cycle1Day1
  • Other protocol defined exclusion criteria may apply

Where in Spain

Also in 3 other countries, 7 sites

  • Hospital Universitari Vall d'Hebron - VHIO - Oncology - Phase I UnitBarcelona, SpainContact: Elena Garralda Cabanas (principal investigator)Not yet recruiting
  • NEXT Madrid - Hospital Universitario Quironsalud MadridMadrid, SpainContact: Valentina Boni (principal investigator)Taking people

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • Part 1: Dose-escalation CohortTreatment being tested

    Treatment: M7437

  • Part 2: Dose-Expansion CohortTreatment being tested

    Treatment: M7437

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests M7437 in adults with advanced solid tumors that have Ly6EGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
20 October 2026