A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors
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
1 other identifier
observational
1,150
1 country
21
Brief Summary
TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous T cells are engineered to express a T cell receptor that recognizes tumor-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) assessment, and expression of Tumor-associated Antigens (TAA) testing. These results will be used to determine if participants meet the eligibility criteria for these parameters and could potentially be enrolled in a TScan clinical study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Typical duration for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2023
CompletedFirst Posted
Study publicly available on registry
April 13, 2023
CompletedStudy Start
First participant enrolled
June 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2027
ExpectedNovember 17, 2025
November 1, 2025
2.5 years
March 31, 2023
November 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of subjects with TAA expression, HLA typing and HLA loss.
To identify participants that could potentially be eligible for the TScan Therapeutics clinical trials.
3 years
Interventions
HLA genotyping and tumor tissue profiling for certain tumor-associated antigens and HLA LOH.
Eligibility Criteria
The purpose of this study is to identify participants with locally advanced (unresectable) or metastatic solid tumors that could potentially be eligible for a TScan clinical study.
You may qualify if:
- Willing and able to provide written informed consent.
- 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.
You may not qualify if:
- Participants undergoing anticancer therapy with curative intent such as tumor surgical resection with or without neoadjuvant/adjuvant therapy, or definitive chemoradiation, unless they have locoregionally advanced disease and are expected to have a high risk of relapse after their curative intent therapy as determined by the treating investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
HonorHealth Research and Innovation Institute
Scottsdale, Arizona, 85258, United States
University of California San Diego
San Diego, California, 92037, United States
Yale Cancer Center
New Haven, Connecticut, 06510, United States
Memorial Healthcare System
Hollywood, Florida, 33021, United States
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Orlando Health
Orlando, Florida, 32806, United States
University of South Florida
Tampa, Florida, 33606, United States
University of Chicago
Chicago, Illinois, 60637, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
University of Minnesota, Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213, United States
Allegheny Hospitals Network
Pittsburgh, Pennsylvania, 15224, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Biospecimen
Diagnostic Test: Tumor Profiling for TAA expression, HLA typing and HLA loss.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dawn Pinchasik, MD
TScan Therapeutics, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2023
First Posted
April 13, 2023
Study Start
June 26, 2023
Primary Completion
January 1, 2026
Study Completion (Estimated)
January 14, 2027
Last Updated
November 17, 2025
Record last verified: 2025-11