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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-26

Study Completion Date

2027-01-14

Brief Summary

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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.

Detailed Description

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This multicenter screening study will be conducted to determine a participant's tumor-associated antigen expression, HLA types and loss of HLA heterozygosity status for potential enrollment in a TScan sponsored clinical study. No treatment intervention will occur as part of this screening study.

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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Head and Neck Cancer Cervical Cancer Non Small Cell Lung Cancer HPV16 Related Cancers Sarcoma Uveal Melanoma NUT Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Tumor and HLA Profiling

HLA genotyping and tumor tissue profiling for certain tumor-associated antigens and HLA LOH.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

• 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TScan Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

University of California San Diego

San Diego, California, United States

Site Status

Yale Cancer Center

New Haven, Connecticut, United States

Site Status

Memorial Healthcare System

Hollywood, Florida, United States

Site Status

University of Miami, Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Site Status

Orlando Health

Orlando, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Norton Cancer Institute

Louisville, Kentucky, United States

Site Status

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

University of Minnesota, Masonic Cancer Center

Minneapolis, Minnesota, United States

Site Status

Columbia University Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Oncology Hematology Care

Cincinnati, Ohio, United States

Site Status

The Cleveland Clinic

Cleveland, Ohio, United States

Site Status

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States

Site Status

Allegheny Hospitals Network

Pittsburgh, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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TSCAN-003

Identifier Type: -

Identifier Source: org_study_id

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