Clinical trialPhase 1Recruiting
Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors
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
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Recruiting
- Study type
- Interventional
- Start
- 13 February 2026
- Expected end
- 28 March 2029
- Enrollment
- 138 participants
- Sites
- 9
- Primary outcomes
- Dose-escalation Cohort: Occurences of Dose Limiting Toxicities (DLTs); Dose-escalation Cohort: Number of Participants With Treatment-Emergent Adverse Event (TEAEs) and Adverse Event (AEs)
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 20 October 2026
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Brief summary public domain (ClinicalTrials.gov)
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).