Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID
NCT07360314
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

First listed
Jan 22, 2026
Start date
Feb 13, 2026
Status verified
Jun 2026
Primary completion
Sep 20, 2028
Completion
Mar 28, 2029

Study Design

Enrollment
138 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Part 1: Dose-escalation Cohort
  • Experimental: Part 2: Dose-Expansion Cohort

Primary Outcome Measure

Dose-escalation Cohort: Occurences of Dose Limiting Toxicities (DLTs) [ Time Frame: DLT period is 21 days (cycle 1) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Yale University - Yale University School of MedicineNew HavenConnecticut06510
203-785-6221
Patricia M LoRusso (PRINCIPAL_INVESTIGATOR)
Carolina BioOncology Institute, LLC - Cancer Therapy and Research CenterHuntersvilleNorth Carolina28078
704-947-6599
John D Powderly (PRINCIPAL_INVESTIGATOR)
NEXT HoustonGalvestonTexas77001
Jennifer M Segar (PRINCIPAL_INVESTIGATOR)
NEXT Oncology - PARENTSan AntonioTexas78229
210-595-5670
Ildefonso Ismael Rodriguez Rivera (PRINCIPAL_INVESTIGATOR)

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Yale University - Yale University School of Medicine· New Haven, CTCarolina BioOncology Institute, LLC - Cancer Therapy and Research Center· Huntersville, NCNEXT Houston· Galveston, TXNEXT Oncology - PARENT· San Antonio, TX

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