Back to search results

Study of M7437 for Advanced Solid Tumors

This study is testing a new drug called M7437 for people with advanced solid tumors that have high levels of a protein called Ly6E. These are cancers that have spread or cannot be removed by surgery, and have not responded to standard treatments, or for which no standard treatment is available. The study aims to find out if M7437 is safe, what dose works best, and if it shows any signs of helping to treat cancers like non-small cell lung cancer, triple-negative breast cancer, and pancreatic cancer. The study plans to enroll 138 participants, but its current status is unclear.

Study design
This is a first-in-human study, meaning it's the first time M7437 is being tested in people. It will involve increasing doses of the drug in small groups of participants to find a safe and effective dose.
What's involved
Participants will receive M7437 as an infusion into a vein. The study will monitor for side effects for about 1 year and 8 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects for approximately 1 year and 8 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07360314

Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors

Recruiting
PHASE1Ages 18+Interventional
EMD Serono Research & Development Institute, Inc.
~138 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:M7437

At a glance

Recruiting sites
6 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-escalation Cohort: Occurences of Dose Limiting Toxicities (DLTs)
Measured over DLT period is 21 days (cycle 1)
+1 more outcome measured

Conditions

Advanced Solid Tumors

Explore related trials

Breast CarcinomaGastric CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaMalignant Ovarian NeoplasmPancreatic Ductal AdenocarcinomaSolid NeoplasmLymphocyte Antigen 6E

Where it's being run

9 sites across 6 states
Texas2
Canada2
Spain2
Connecticut1
North Carolina1
Japan1

Study leadership

  • Medical Responsible · STUDY_DIRECTOR · EMD Serono Research & Development Institute, Inc.

Who to contact

US Medical Information
[email protected]
888-275-7376
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.
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.

Exclusion

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:
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.

What this trial measures

  • 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)