First-in-Human SynKIR-110 Shows Safe Profile and Early Activity in Solid Tumors

Overview

• Early Phase 1 data presented at the AACR Annual Meeting reported outcomes from nine patients with mesothelin-positive ovarian cancer, mesothelioma, or cholangiocarcinoma in the STAR-101 trial.
• Investigators observed no dose-limiting toxicities, low-grade cytokine release syndrome in three of nine patients, and no cases of neurotoxicity.
• Preliminary efficacy signals included one ongoing partial response in the highest dose cohort and disease stabilization in four heavily pretreated patients.
• Blood tests showed dose-dependent expansion and persistence of the engineered T cells, indicating on-target biologic activity at higher doses.
• The study is continuing dose escalation to define a Phase 2 dose with up to 42 patients planned, a step that could widen cell therapy options for people with solid tumors if safety and benefit hold up in larger cohorts.