Last updated on July 2019

MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors


Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT02517398

Find a site near you

Start Over

Liverpool Hospital

Liverpool, Australia
  Connect »

Southampton General Hospital

Southampton, United Kingdom
  Connect »

Winship Cancer Institute

Atlanta, GA United States
  Connect »

Northern Centre for Cancer Care

Newcastle upon Tyne, United Kingdom
  Connect »

The Queen Elizabeth Hospital

Woodville South, Australia
  Connect »

Washington University

Saint Louis, MO United States
  Connect »

H pital Cochin

Paris cedex 14, France
  Connect »

Asan Medical Center

Seoul, Korea, Republic of
  Connect »

H pital Saint-Louis

Paris Cedex 10, France
  Connect »

Sylvester Cancer Center

Miami, FL United States
  Connect »

Guy's Hospital

London, United Kingdom
  Connect »

Blacktown Hospital

Blacktown, Australia
  Connect »

California Pacific Medical Center

San Francisco, CA United States
  Connect »

Samsung Medical Center

Seoul, Korea, Republic of
  Connect »

Michigan State University

Lansing, MI United States
  Connect »

Tennessee Cancer Specialists

Knoxville, TN United States
  Connect »

Pacific Oncology Associates

Escondido, CA United States
  Connect »

Lynn Cancer Institute Center

Boca Raton, FL United States
  Connect »

Northside Hospital

Atlanta, GA United States
  Connect »

Metairie Oncologists, LLC

Metairie, LA United States
  Connect »

National Cancer Institute

Bethesda, MD United States
  Connect »

Henry Ford Health System

Detroit, MI United States
  Connect »

Rhode Island Hospital

Providence, RI United States
  Connect »

Oncology Consultants, P.A.

Houston, TX United States
  Connect »

UZ Antwerpen

Edegem, Belgium
  Connect »

Centre Paul Strauss

Strasbourg Cedex, France
  Connect »

H pital de la Timone#

Marseille cedex 5, France
  Connect »

National Cancer Center

Goyang-si, Korea, Republic of
  Connect »

Queen Mary University of London

London Olney, United Kingdom
  Connect »

The Christie

Manchester, United Kingdom
  Connect »

Queen Elizabeth Hospital

Birmingham, United Kingdom
  Connect »

Jesse Brown V.A.

Chicago, IL United States
  Connect »

Compass Oncology

Vancouver, WA United States
  Connect »

Rcca Md Llc

Bethesda, MD United States
  Connect »

H pital Henri Mondor

Créteil Cedex, France
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.