NCT07360314

Brief 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P75+ for phase_1

Timeline
34mo left

Started Feb 2026

Typical duration for phase_1

Geographic Reach
4 countries

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Feb 2026Mar 2029

First Submitted

Initial submission to the registry

January 13, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

February 13, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2029

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

2.6 years

First QC Date

January 13, 2026

Last Update Submit

June 10, 2026

Conditions

Advanced Solid Tumors

Keywords

Ly6E expressionTopoisomerase I inhibitor (TOP1i)NSCLCBreast cancerGastric cancerHead and neck squamous cell carcinomaOvarian cancerPancreatic ductal adenocarcinomaSystemic antibody-drug conjugate therapy (ADC) therapy

Outcome Measures

Primary Outcomes (2)

  • 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)

Secondary Outcomes (3)

  • Dose-escalation Cohort: Plasma Concentration of M7437

    Cycle 1 Day 1: Pre-dose, 0.25, 6, 24, 96, 168 and 336 hours post-dose; Cycle 3 Day 1: Pre-dose, 0.25, 6 and 168 hours post-dose; Pre-dose at Day 1 of Cycles 2, 4, 6, 8 until end of treatment (approximately 1 year 8 months) (Each Cycle length=21 days)

  • Dose-escalation Cohort: Overall Response (OR) According to Response Evaluation Criteria inSolid Tumor (RECIST) version 1.1 criteria as Assessed by Investigator

    From the date of first documented complete response (CR) or partial response (PR), whichever occurs first, until the first documented disease recurrence or progressive disease (PD) (assessed upto [approximately 1 year 8 months])

  • Change From The Baseline Qtc (Δqtc) At Predefined Timepoints Based on Triplicate Electrocardiogram (ECG) Measurements

    Baseline, Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 5, Cycle 1 Day 8, Cycle 2 Day 1, Cycle 3 Day 1 (each cycle is of 21 days)

Study Arms (2)

Part 1: Dose-escalation Cohort

EXPERIMENTAL
Drug: M7437

Part 2: Dose-Expansion Cohort

EXPERIMENTAL
Drug: M7437

Interventions

M7437DRUG

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.

Part 1: Dose-escalation Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Yale University - Yale University School of Medicine

New Haven, Connecticut, 06510, United States

NOT YET RECRUITING

Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center

Huntersville, North Carolina, 28078, United States

RECRUITING

NEXT Houston

Galveston, Texas, 77001, United States

RECRUITING

NEXT Oncology - PARENT

San Antonio, Texas, 78229, United States

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, 08035, Spain

NOT YET RECRUITING

NEXT Madrid - Hospital Universitario Quironsalud Madrid

Madrid, Spain

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

Breast NeoplasmsStomach NeoplasmsSquamous Cell Carcinoma of Head and NeckOvarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeHead and Neck NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Medical Responsible

    EMD Serono Research & Development Institute, Inc.

    STUDY DIRECTOR

Central Study Contacts

US Medical Information

CONTACT

888-275-7376eMediUSA@emdserono.com

Communication Center

CONTACT

+49 6151 72 5200service@emdgroup.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 22, 2026

Study Start

February 13, 2026

Primary Completion (Estimated)

September 20, 2028

Study Completion (Estimated)

March 28, 2029

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website http://bit.ly/IPD21

Locations

US(4)JP(1)CA(2)ES(2)