Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors

NCT ID: NCT07311603

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-02
• Study Completion Date: 2029-03-28

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

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Part 2: Dose-Expansion Cohort

Group Type: EXPERIMENTAL

M7437

Intervention Type: DRUG

Participants will receive M7437 at a dose that was determined as recommended dose for expansion (RDE) in Part 1.

Part 1: Dose-escalation Cohort

Group Type: EXPERIMENTAL

M7437

Intervention Type: DRUG

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.

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.

Intervention Type: DRUG

M7437

Participants will receive M7437 at a dose that was determined as recommended dose for expansion (RDE) in Part 1.

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: collaborator

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Locations

Research Site

Darmstadt, , Germany

Countries

Germany

Central Contacts

Communication Center

Role: CONTACT

Phone: +49 6151 72 5200

Email: service@emdgroup.com

Related Links

https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS743701_0001

Trial Awareness and Transparency website

https://www.merckgroup.com/en/company/contact-us/medinfo-contact-map.html

Medical Information Location Map - Med Info Contacts

Other Identifiers

176325

Identifier Type: OTHER

Identifier Source: secondary_id

2025-523232-39-00

Identifier Type: CTIS

Identifier Source: secondary_id

MS743701_0001

Identifier Type: -

Identifier Source: org_study_id