VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Trial Parameters
Brief Summary
This is a multicenter, open-label, Phase 1/2 study of orally administered VMD-928 monotherapy and in combination with pembrolizumab in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists
Eligibility Criteria
Key Inclusion Criteria: #. Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma: Phase 1 Dose Escalation only: Subjects with (A) any advanced solid tumors of 1. Head and Neck Cancers ("HNC") (of any types), 2. Esophageal cancer, 3. Lung cancers (of any types), 4. Mesothelioma, 5. Pancreatic cancers, Or, (B) any NTRK1 gene fusion positive ("NTRK1+") solid tumors or lymphomas, that is relapsed, refractory or intolerant (R/R/I) to standard of care (SOC) and for which there is no approved or curative therapy. Additionally, patients must not be candidates for or have exhausted regimens known to provide clinical benefit, including hematopoietic stem cell transplantation in lymphoma patients if they are deemed transplant eligible. Phase 2 Monotherapy and Combination with Pembrolizumab only: Subjects must have 1. TrkA-driven HNC, Esophageal, Lung, Mesothelioma, Pancreatic cancers; or, 2. any NTRK1+ solid tumors or lymphoma\*, that is R/R/I to SO