A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors
NCT ID: NCT05812027
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1150 participants
OBSERVATIONAL
2023-06-26
2027-01-14
Brief Summary
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Detailed Description
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Participants will be required to provide a buccal swab to assess their HLA types and a saliva sample to assess for HLA loss of heterozygosity. For participants with an HLA type for which TScan has an open clinical study, archival tissue (less than 8 months old) will be needed to assess for tumor-associated antigen expression. If archival tissue is not available or older than 8 months, a fresh tumor biopsy will be required.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Tumor and HLA Profiling
HLA genotyping and tumor tissue profiling for certain tumor-associated antigens and HLA LOH.
Eligibility Criteria
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Inclusion Criteria
* Male or female aged ≥18 years at the time of signing the informed consent.
* Have one of the following histologically or cytologically confirmed locally advanced (unresectable) or metastatic solid tumor for which the Sponsor has an associated clinical study:
* Head and neck cancer
* Cervical cancer
* Non-small cell lung cancer
* HPV positive anogenital cancers
* Sarcoma
* Other cancers with a reasonable likelihood of expressing 1 or more antigens included in a TScan clinical trial, following approval by the TScan Medical Monitor or their delegate.
* Willing to provide a buccal swab for HLA testing
* Willing to provide a saliva sample to use as a normal control for the LOH assay
* Have access to an adequate FFPE tumor block that is \<8 months old or is willing to provide a fresh core-needle biopsy from a location deemed safe by the treating medical team.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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TScan Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dawn Pinchasik, MD
Role: STUDY_DIRECTOR
TScan Therapeutics, Inc.
Locations
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HonorHealth Research and Innovation Institute
Scottsdale, Arizona, United States
University of California San Diego
San Diego, California, 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
University of South Florida
Tampa, Florida, United States
University of Chicago
Chicago, Illinois, 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
Oncology Hematology Care
Cincinnati, Ohio, United States
The Cleveland Clinic
Cleveland, Ohio, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 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
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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Other Identifiers
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TSCAN-003
Identifier Type: -
Identifier Source: org_study_id
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