Spots Global Cancer Trial Database for Study of JTX-8064, as Monotherapy and in Combination With a PD-1 Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumors
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Trial Identification
Brief Title: Study of JTX-8064, as Monotherapy and in Combination With a PD-1 Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumors
Official Title: Phase 1/2 First-in-Human (FIH) Study of Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2) Inhibitor Monoclonal Antibody (mAb) JTX-8064, as Monotherapy and in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumor Malignancies
Study ID: NCT04669899
Conditions
Study Description
Brief Summary: JTX-8064-101 is a Phase 1/2, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose (RP2D) of JTX-8064 alone and in combination with a PD-1 inhibitor (PD-1i).
Detailed Description: JTX-8064 is a humanized mAb designed to block the interaction of LILRB2 with its known ligands, endogenous major histocompatibility complex class I (MHC I) molecules. This is a Phase 1/2, first in human, open label, multicenter, dose escalation and dose expansion clinical trial to determine the safety, tolerability, maximum tolerated dose (MTD) and RP2D of JTX-8064 when administered as a single agent and in combination with a PD-1i in adult subjects with advanced refractory solid tumor malignancies. Additionally, the study will seek to evaluate the pharmacokinetics and immunogenicity of JTX-8064, and preliminary efficacy of JTX-8064 as a monotherapy and in combination with a PD-1i.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Arizona Clinical Research Center, Tucson, Arizona, United States
University of Arkansas Medical Sciences, Little Rock, Arkansas, United States
City of Hope, Duarte, California, United States
California Cancer Associates for Research & Excellence, Inc., La Jolla, California, United States
University of California, San Diego, La Jolla, California, United States
Cedars Sinai, Los Angeles, California, United States
UC Irvine Medical Center, Orange, California, United States
University of California, Davis, Sacramento, California, United States
Yale University, New Haven, Connecticut, United States
Georgetown University, Washington, District of Columbia, United States
University of Florida, Gainesville, Florida, United States
University of Miami - Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Adventist Health System/Sunbelt, Inc., Orlando, Florida, United States
Tampa General Hospital, Tampa, Florida, United States
Augusta Oncology Associates - Wheeler Road, Augusta, Georgia, United States
University of Chicago, Chicago, Illinois, United States
Cancer Care Center of Decatur, Decatur, Illinois, United States
University of Kentucky Chandler Medical Center (UKCMC), Lexington, Kentucky, United States
University of Michigan, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Center, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
START Midwest -Cancer & Hematology Center of Western Michigan, Grand Rapids, Michigan, United States
Regents of the University of Minnesota, Minneapolis, Minnesota, United States
Weill Cornell, New York, New York, United States
Mount Sinai, New York, New York, United States
Montefiore Medical Center PRIME, New York, New York, United States
Carolina BioOncology, Huntersville, North Carolina, United States
Gabrail Cancer Center, Canton, Ohio, United States
UC Health, LLC, Cincinnati, Ohio, United States
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Providence Portland Cancer Center, Portland, Oregon, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Prisma Health, Greenville, South Carolina, United States
Mary Crowley Cancer Research, Dallas, Texas, United States
Oncology Consultants, P.A., Houston, Texas, United States
MD Anderson, Houston, Texas, United States
Joe Arrington Cancer Research & Treatment Center, Lubbock, Texas, United States
START Texas Accelerated Research Therapeutics, San Antonio, Texas, United States
START Mountain Region, West Valley City, Utah, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
The Board of Regents of the University of Wisconsin, Madison, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Stew Kroll
Affiliation: Jounce Therapeutics, Inc.
Role: STUDY_DIRECTOR
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