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Clinical Trials/NCT07360314
NCT07360314
Recruiting
Phase 1

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

EMD Serono Research & Development Institute, Inc.17 sites in 4 countries138 target enrollmentStarted: February 13, 2026Last updated:
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InterventionsM7437

Overview

Phase
Phase 1
Status
Recruiting
Enrollment
138
Locations
17
Primary Endpoint
Dose-escalation Cohort: Occurences of Dose Limiting Toxicities (DLTs)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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).

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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:
  • •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 Cycle1Day
  • •Participants with active chronic inflammatory bowel disease and/or bowel obstruction.
  • •Participants with history of serious gastrointestinal bleeding within 3 months of Cycle1Day
  • •Other protocol defined exclusion criteria may apply.

Arms & Interventions

Part 2: Dose-Expansion Cohort

Experimental

Intervention: M7437 (Drug)

Part 1: Dose-escalation Cohort

Experimental

Intervention: M7437 (Drug)

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • 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))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (17)

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