A First-in-Human, Open Label, Dose Escalation Study of MVC-101, An EGFR x CD3 COBRA™ Protein in Patients with Unresectable Locally Advanced or Metastatic Cancer
Study Phase: Phase 1/2
Study Purpose: The primary purpose of this study is to characterize the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary anti-tumor activity of MVC-101 in patients with unresectable, locally advanced or metastatic cancer.
Lead Product Candidate Background: In preclinical models with established human tumors, MVC-101 demonstrated substantial anti-tumor activity and regressions across multiple tumor types that express EGFR. Exposures of MVC-101 at efficacious relative to tolerated doses in safety studies reveal that this conditionally active COBRA™ molecule has an increased therapeutic index compared to that of inherently active standard T cell engagers. MVC-101 is designed to be a universal solution for patients with EGFR-expressing solid tumor cancers.