Study of Oral VMD-928 Alone and With Pembrolizumab in Adults With Solid Tumors or Lymphoma Overexpressing TrkA

What this Trial Is About

Researchers are evaluating VMD-928, taken alone or combined with pembrolizumab, in adults with advanced solid tumors or lymphoma that have not responded to other treatments or have no available curative options. This open-label Phase 12 study focuses on cancers with TrkA protein overexpression, including head and neck cancers, esophageal, lung, mesothelioma, and pancreatic cancers. The trial aims to find safe and active doses, especially in tumors driven by TrkA protein or NTRK1 gene fusions. Participants receive oral VMD-928 tablets daily in 21-day cycles either alone or with pembrolizumab given intravenously every 21 days up to six cycles. The study includes a dose-escalation phase to find recommended doses and a phase to assess antitumor activity. Pembrolizumab is fixed at 200 mg per dose when combined. Tissue samples are tested for TrkA protein to confirm eligibility. During the study, participants undergo regular monitoring including safety assessments, pharmacokinetic tests, tumor evaluations, and lab tests. Researchers track adverse events and tumor response over up to 18 months. The study also examines drug levels in blood and the relationship between tumor protein expression and treatment effects. Participants are followed closely during treatment cycles and through the study duration to evaluate safety and effectiveness.

VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma