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

This is 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 will be
explored in two dose escalation groups in accessible cutaneous or subcutaneous lesions, as
well as an optional dose confirmation group exploring intratumoral injection of viscerally
located lesions.

Group A will include patients with accessible solid tumors and lymphomas. This group will
receive 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 will
include patients with accessible solid tumors and lymphomas. This group will receive a fixed
dose of PDR001 i.v. on day 1 of every cycle and an intratumoral injection of MIW815
(ADU-S100) on day 1 of every cycle.

Once the dose and dose schedule has been confirmed, the dose expansion part of the study will
open. The main purpose of the expansion part is to further assess the safety and
tolerability, as well as preliminary anti-tumor activity, of the study treatment at the
maximum tolerated dose and/or recommended dose for expansion. .

Inclusion Criteria:

ECOG ≤ 1 Willing to undergo tumor biopsies from injected and distal lesions

Must have two biopsy accessible lesions:

Exclusion Criteria:

Symptomatic or untreated leptomeningeal disease. Presence of symptomatic central nervous
system metastases Impaired cardiac function or clinically significant cardiac disease
Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or
resolved childhood asthma/atopy.

Active infection requiring systemic antibiotic therapy. Known history of human
immunodeficiency virus infection. Active Epstein-Barr virus, hepatitis B virus or hepatitis
C virus Malignant disease, other than that being treated in this study