MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

The main purpose of this Phase I study was 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.

Key facts

Study ID: NCT02517398
Run by: EMD Serono Research & Development Institute, Inc.
People needed: 600
Starts: 2015-08-31
Expected to finish: 2022-05-23
Last updated by the study team: 2024-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Ability to understand the purpose of the study, provide signed and dated informed consent, and able to comply with all procedures
In Japan, if a subject is < 20 years, the written informed consent from his/her parent or guardian will be required in addition to the subject's written consent
Male or female subjects aged greater than or equal to (>=) 18 years
Life expectancy >= 12 weeks as judged by the Investigator
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry
Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Adequate hematological, hepatic and renal function as defined in the protocol
Effective contraception for both male and female subjects if the risk of conception exists
Other protocol-defined inclusion criteria could apply.

You may not qualify if…

Concurrent treatment with non-permitted drugs and other interventions
Anticancer treatment within 28 days before the start of trial treatment, for example cyto reductive therapy, radiotherapy (with the exception of palliative radiotherapy delivered in a normal organ-spearing technique), immune therapy, or cytokine therapy
Major surgery within 28 days before the start of trial treatment (prior diagnostic biopsy is permitted)
Systemic therapy with immunosuppressive agents within 7 days before the start of trial treatment; or use of any investigational drug within 28 days before the start of trial treatment
Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Subjects with history of cervical carcinoma in situ, superficial or non invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded. Subjects with other localized malignancies treated with curative intent need to be discussed with the Medical Monitor.
Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures
Subjects with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention are excluded
Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (eg, corneal transplant, hair transplant)
Other protocol-defined exclusion criteria could apply

Where it is running

Pacific Oncology Associates — Escondido, California, United States
University of California Davis Health System — Sacramento, California, United States
California Pacific Medical Center — San Francisco, California, United States
Innovative Clinical Research Institute — Whittier, California, United States
Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States
Eastern Connecticut Hematology/Oncology Assoc. — Norwich, Connecticut, United States
Sylvester Cancer Center — Miami, Florida, United States
Hematology - Oncology Associates of Treasure Coast — Port Saint Lucie, Florida, United States
University Cancer & Blood Center, LLC — Athens, Georgia, United States
Southeastern Regional Medical Center — Newnan, Georgia, United States
Metairie Oncologists, LLC — Metairie, Louisiana, United States
National Cancer Institute — Bethesda, Maryland, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
Henry Ford Health System — Detroit, Michigan, United States
Michigan State University — Lansing, Michigan, United States
Washington University — St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
UC Health Clinical Trials Office — Cincinnati, Ohio, United States
Case Comprehensive Cancer Center — Cleveland, Ohio, United States
Penn State University Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
Rhode Island Hospital — Providence, Rhode Island, United States
Medical University of South Carolina — Charleston, South Carolina, United States
Greenville Hospital System University Medical Center (ITOR) — Greenville, South Carolina, United States
Arizona Clinical Research Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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