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Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Lead sponsor: EMD Serono Research & Development Institute, Inc. to EMD Serono Research & Development Institute, Inc. Primary completion date: Sep 20, 2028 to Sep 28, 2028 · Eligibility criteria expanded, about 18 words · Site details revised at 1 of 9 sites Show 3 more changesShow less
    • Primary completion date: Sep 20, 2028 to Sep 28, 2028
    • Eligibility criteria expanded, about 18 words
    • Site details revised at 1 of 9 sites
  2. Minor Re-verified, no change to tracked fieldsv9
  3. Minor Site details revised at 1 of 9 sites Collaborator revisedv8 Show 1 more changeShow less
  4. Minor 2 versions Re-verified since Jun 10, 2026, no change to tracked fieldsv6-v7
  5. Minor Site details revised at 1 of 9 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Minor Study sites: 8 to 9v4
  2. Minor Re-verified, no change to tracked fieldsv3
  3. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 30, 2026 to Feb 13, 2026 · Site details revised at 8 of 8 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Jan 30, 2026 to Feb 13, 2026
    • Site details revised at 8 of 8 sites
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
43 trials monitored
See 4 trials at risk
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 Details
NCT Number NCT07360314
Lead Sponsor EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany
Conditions Advanced Solid Tumors
Enrollment 138 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov