Summary

The main purpose of this Phase I study is to test MSB0011359C (M7824) at different dose
levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means
the study drug has not previously been given to humans or has only been given to a limited
number of people, although it has been extensively studied in animals. Based on this
information, it is hoped to find out which dose could be best for the treatment of patients.
There are two parts of this research study: a dose-escalation part and an expansion part.
Dose escalation means that the first people taking part in the study will receive low doses
of the study drug, and as more people take part, the additional participants will receive a
higher dose. This is done to find the safest dose for the study drug. Expansion means that
after the dose-escalation part of the study has looked at the safety and effectiveness of
different doses, many more people will be invited to take part in the study and will receive
the study drug at the safest dose. Additional purposes of the study are to find out whether
the study drug has anti-cancer effects and how the study drug is processed by the body.

Objectives

This is a Phase I, open-label, dose-escalation trial with consecutive parallel-group
expansion in selected solid tumor indications. The current trial is composed of a standard
dose escalation "3 + 3" cohort design, for which 3 to 6 subjects will be enrolled at each
dose level depending on the occurrence of dose limiting toxicities (DLTs), followed by a
consecutive parallel-group expansion in selected solid tumor indications. Cohorts of 3
subjects with metastatic or locally advanced solid tumors, for which no standard effective
therapy exists or standard therapy has failed, will receive MSB0011359C (M7824) at escalating
dose levels. After determination of the Maximum tolerated dose (MTD), enrollment in several
expansion cohorts will be opened to determine the safety, pharmacokinetic (PK) /
Pharmacodynamic, and clinical activity of MSB0011359C (M7824). Subjects who have experienced
a confirmed complete response (CR) should continue treatment through the end of 12 months,
although additional treatment is possible. In the case of progressive disease (PD), subjects
should continue treatment through their next tumor assessment. Additional indications will be
planned based on emerging data in the field.