Metastatic/Locally Advanced Solid Tumors EMR200647-001

May 09, 2017

Sponsor: EMD Serono Research & Development Institute, Inc.

Number: EMR200647-001

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 in patients with metastatic or locally advanced solid tumors. 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.

Who’s eligible:

• The patient must have a life expectancy >= 12 weeks as judged by the Investigator. There must be an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry. ECOG status is used by your doctor in order to assess how your disease is progressing, assess how the disease effects of your daily living abilities, and determine appropriate treatment and prognosis.
• The disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Recist 1.1; a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment. There must be adequate hematological, hepatic and renal function as defined in the protocol.
• The patient must use effective contraception (birth control) for both male and female subjects if the risk of conception exists.
• This study is for patients age 18 and older.

Available at: Backus Hospital- Eastern Connecticut Hematology and Oncology.