This Phase 1/2, first-in-human, open-label, multicenter study aims to determine the safest and most effective dose (Maximum Tolerated Dose, MTD, or Recommended Phase 2 Dose, RP2D) of LNS8801, both on its own and in combination with pembrolizumab. Using a 3+3 dose escalation design, the study will evaluate the safety, tolerability, how the drug behaves in the body (pharmacokinetics), and its ability to fight tumours.
The trial includes three stages: a dose escalation phase to find the optimal dose, a dose expansion phase to further test the treatment, and Phase 2A cohorts to assess its effectiveness in specific patient groups. Up to 200 patients will take part, and the study will be conducted at up to 15 sites across the United States.