Spots Global Cancer Trial Database for Study of CHS-388 (Formerly Known as SRF388) in Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: Study of CHS-388 (Formerly Known as SRF388) in Patients With Advanced Solid Tumors
Official Title: A Phase 1/1b Study of CHS-388 (Formerly Known as SRF388) in Patients With Advanced Solid Tumors
Study ID: NCT04374877
Study Description
Brief Summary: This is a Phase 1/1b, open-label, first-in-human, dose-escalation and expansion study of CHS-388, a monoclonal antibody that targets IL-27, as a monotherapy and in combination in patients with solid tumors.
Detailed Description: This is a Phase 1/1b, open-label, first-in-human (FIH), dose-escalation and expansion study of CHS-388, a monoclonal antibody targeting IL-27, as a monotherapy and in combination in patients with solid tumors that will be conducted in 4 parts: * Part A: CHS-388 monotherapy dose-escalation portion of the study will evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of CHS-388 as monotherapy in patients with advanced solid tumors. * Part B: CHS-388 monotherapy expansion cohorts will evaluate the safety, efficacy, tolerability, PK, and pharmacodynamics of CHS-388 monotherapy in patients with advanced or metastatic ccRCC, advanced or metastatic HCC, and advanced or metastatic NSCLC in indication specific cohorts. * Part C will evaluate the safety, preliminary efficacy, tolerability, and PK of CHS-388 in combination with pembrolizumab in patients with advanced RCC,HCC, or NSCLC. * Part D will evaluate the safety, preliminary efficacy, tolerability, and PK of CHS-388 in combination with toripalimab in patients with advanced NSCLC.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
University of Southern California (USC) - Norris Comprehensive Cancer Center, Los Angeles, California, United States
UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
University of Miami Leonard M. Miller School of Medicine (UMMSM), Miami, Florida, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Health System (UMHS), Ann Arbor, Michigan, United States
Washington University School of Medicine - St. Louis, Saint Louis, Missouri, United States
Roswell Park, Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH), New York, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center (OUHSC) - Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center (University of Pittsburgh Cancer Institute (UPCI)), Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center (VUMC), Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
The University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
National University Hospital, Singapore, , Singapore
National Cancer Center Singapore (NCCS), Singapore, , Singapore
Contact Details
Name: Koho Iizuka, MD
Affiliation: Coherus BioSciences
Role: STUDY_CHAIR
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