Recruiting
Phase 1

M7437

Sponsor:

EMD Serono Research & Development Institute, Inc.

Code:

NCT07360314

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

M7437

M7437

Study Details

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).

Conditions

Advanced Solid Tumors

Study ID

NCT07360314

Start date

Feb 13, 2026

Status verified date

Aug, 2026

Completion date

Mar 28, 2029

Anticipated

Primary completion date

Sep 20, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

138 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Part 1: Dose-escalation Cohort

experimental: Part 2: Dose-Expansion Cohort

Interventions

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.

Primary outcome measure

  • Dose-escalation Cohort: Occurences of Dose Limiting Toxicities (DLTs) [ Time Frame: DLT period is 21 days (cycle 1) ]
  • Dose-escalation Cohort: Number of Participants With Treatment-Emergent Adverse Event (TEAEs) and Adverse Event (AEs) [ Time Frame: Up to end of Part 1 of study (approximately 1 year 8 months) ]

Central Contacts and Locations

Central contacts

US Medical Information

888-275-7376eMediUSA@emdserono.com

Communication Center

+49 6151 72 5200service@emdgroup.com

Locations

Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center

Recruiting

Huntersville, North Carolina, United States, 28078

Contacts

704-947-6599

Principal Investigator:

John D Powderly

NEXT Houston

Recruiting

Galveston, Texas, United States, 77001

Principal Investigator:

Jennifer M Segar

NEXT Oncology - PARENT

Recruiting

San Antonio, Texas, United States, 78229

Contacts

210-595-5670

Principal Investigator:

Ildefonso Ismael Rodriguez Rivera

Princess Margaret Cancer Centre

Recruiting

Toronto, Canada

Contacts

Spreafico

Principal Investigator:

Anna Spreafico

More Information

Sponsor

EMD Serono Research & Development Institute, Inc.

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Ly6E expression
  • Topoisomerase I inhibitor (TOP1i)
  • NSCLC
  • Breast cancer
  • Gastric cancer
  • Head and neck squamous cell carcinoma
  • Ovarian cancer
  • Pancreatic ductal adenocarcinoma
  • Systemic antibody-drug conjugate therapy (ADC) therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by EMD Serono Research & Development Institute, Inc. on 2026-08-17.