Study of the Safety and Efficacy of MIW815 With PDR001 in Patients With Advanced/Metastatic Solid Tumors or Lymphomas

This was a Phase Ib, multi-center, open-label study to characterize the safety,

tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of

MIW815(ADU-S100) in combination with the PD-1 checkpoint inhibitor PDR001. Two different

schedules were explored in two dose escalation groups in accessible cutaneous or

subcutaneous lesions. The optional dose confirmation group exploring intratumoral

injection of viscerally located lesions was not opened due to the program's early

termination.

Group A included patients with accessible solid tumors and lymphomas. This group received

a fixed dose of PDR001 i.v. on day 1 of every 28 day cycle and intratumoral injections of

MIW815 (ADU-S100) on days 1, 8 and 15 of every 28 day cycle. Group B included patients

with accessible solid tumors and lymphomas. This group received a fixed dose of PDR001

i.v. on day 1 of every 28 day cycle and an intratumoral injection of MIW815 (ADU-S100) on

day 1 of every 28 day cycle.

Once the dose and dose schedule had been confirmed, the plan was to open the dose

expansion part of the study. However, the expansion phase of the study was not opened to

enrollment due to the program's early termination.