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
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).
• 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.
⁃ Other protocol defined inclusion criteria may apply