Clinical Study Design
INDUCE-1 (NCT02723955) is an ongoing phase I, multicenter, open-label study that consists of two parts: (Part 1) feladilimab alone and (Part 2) feladilimab in combination with other therapies, including pembrolizumab. Each part includes a dose-escalation (Part 1A and 2A) and dose-expansion phase (Part 1B and 2B). In Part 1A, patients received escalating doses of feladilimab monotherapy (intravenous, day 1, once every 3 weeks) ranging from 0.001 to 10 mg/kg feladilimab. In Part 1B, patients received feladilimab monotherapy (intravenous, day 1, once every 3 weeks) at doses selected for evaluation in the dose-escalation phase and based on their pharmacology. In Part 2A, patients received escalating doses of feladilimab (0.001 to 3 mg/kg) in combination with a fixed dose (200 mg) of pembrolizumab (intravenous, day 1, once every 3 weeks). In Part 2B, patients received feladilimab in combination with a fixed dose (200 mg) of pembrolizumab (intravenous, day 1, once every 3 weeks) at the doses selected for evaluation in the dose-escalation phase and based on their pharmacology.The study was conducted in accordance with the Declaration of Helsinki and International Conference on Harmonization Good Clinical Practice guidelines. Patients provided written informed consent; all human biological samples were sourced ethically, and their research use was in accordance with the terms of the informed consents under a protocol approved by the relevant Institutional Review Boards/ethics committees.No significant updates have been made to the protocol with regards to statistical assumptions or methods after trial commencement.