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Brief Title: A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors
Official Title: Screening Study to Determine HLA Type, HLA Loss of Heterozygosity Status and Tumor Antigen Expression in Participants With Locally Advanced (Unresectable) or Metastatic Solid Tumors
Study ID: NCT05812027
Brief Summary: TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous participant-derived T cells are engineered to express a T cell receptor that recognizes cancer-associated antigens presented on specific Human Leukocyte Antigen (HLA) molecules. The purpose of this screening study is to collect samples to conduct HLA genotyping, HLA Loss of Heterozygosity (LOH) and expression of Tumor-associated Antigens (TAA) testing. These results will be used to determine if subjects meet the eligibility criteria for these parameters and could potentially be enrolled in a TScan clinical treatment study.
Detailed Description: This multicenter screening study will be conducted to determine a subject's tumor antigen expression profile, HLA genotype and HLA LOH for TScan sponsored clinical treatment study(s). No treatment intervention will occur as part of this screening study. Subjects will be required to provide a buccal swab to assess their HLA status. If they are positive for certain types of HLA, subjects will provide a saliva sample to assess HLA loss of heterozygosity. In parallel, archival tissue (less than 8 months old) will be needed to assess for tumor antigen expression. If archival tissue is older than 8 months, a fresh tumor biopsy will be required at the time of the second visit. If eligible, subjects will be referred to appropriate available interventional trial(s) at the discretion of the Investigator.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
HonorHealth Research and Innovation Institute, Scottsdale, Arizona, United States
Yale Cancer Center, New Haven, Connecticut, United States
Memorial Healthcare System, Hollywood, Florida, United States
University of Miami, Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Orlando Health, Orlando, Florida, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
University of Minnesota, Masonic Cancer Center, Minneapolis, Minnesota, United States
Columbia University Herbert Irving Comprehensive Cancer Center, New York, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
The Cleveland Clinic, Cleveland, Ohio, United States
Providence Cancer Institute Franz Clinic, Portland, Oregon, United States
Allegheny Hospitals Network, Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Name: Dawn Pinchasik, MD
Affiliation: TScan Therapeutics, Inc.
Role: STUDY_DIRECTOR