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NCT07360314 · ClinicalTrials.gov registry record · Phase 1

Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors

A Phase 1 study of Advanced Solid Tumors, sponsored by EMD Serono Research & Development Institute.

Recruiting
Registry status
Phase 1
Development phase
138
Enrollment target
8
Study locations

NCT07360314 is a Phase 1 study of Advanced Solid Tumors that is actively recruiting participants, run by EMD Serono Research & Development Institute. The registered enrollment target is 138 participants, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (30% lower). The trial reports 8 study locations across 4 states.

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The verdict

NCT07360314, a Phase 1 study of Advanced Solid Tumors, is actively recruiting participants, sponsored by EMD Serono Research & Development Institute.

RECRUITING
Registry status
Phase 1
Development phase
138 participants
Enrollment target
8
Study locations

Study 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 Studied

Interventions

  • DRUG M7437

Study Locations (8)

Other

  • Princess Margaret Cancer Centre - Toronto
  • BC Cancer - Vancouver - BC Cancer Agency - Vancouver
  • National Cancer Center Hospital - Tokyo
  • NEXT Madrid - Hospital Universitario Quironsalud Madrid - Madrid

Texas

  • NEXT Houston - Galveston
  • NEXT Oncology - PARENT - San Antonio

Connecticut

  • Yale University - Yale University School of Medicine - New Haven

North Carolina

  • Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center - Huntersville

Trial Details

FieldValue
Enrollment Target 138 participants
Start Date 2026-02-13
Est. Completion 2029-03-28
Phase Phase 1

What the Registry Record Tells You About NCT07360314

The ClinicalTrials.gov registry entry for NCT07360314 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (30% lower). The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which M7437 is the first listed.

NCT07360314 reports 8 study locations spanning 4 distinct geographic areas - top geographies include Other, Texas, Connecticut.

Frequently Asked Questions

What is clinical trial NCT07360314 about?

NCT07360314 is a clinical study titled "Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors". 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-...

What is the current status of trial NCT07360314?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 138 participants. The study started on 2026-02-13. Estimated completion is 2029-03-28.

What conditions does trial NCT07360314 study?

This clinical trial studies the following conditions: Advanced Solid Tumors.

What interventions are being tested in trial NCT07360314?

The interventions under investigation include: M7437 (DRUG).

Who is sponsoring clinical trial NCT07360314?

This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07360314 being conducted?

This trial has 8 study locations across Connecticut, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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