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NCT05812027 | RECRUITING | Head and Neck Cancer

A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors
Sponsor:

TScan Therapeutics, Inc.

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 participants meet the eligibility criteria for these parameters and could potentially be enrolled in a TScan clinical treatment study.

Condition or disease

Head and Neck Cancer

Cervical Cancer

Non Small Cell Lung Cancer

Melanoma

Ovarian Cancer

HPV16 Related Cancers

Intervention/treatment

Tumor and HLA Profiling

Detailed Description:

This multicenter screening study will be conducted to determine a participant's tumor antigen expression profile, HLA genotype and loss of HLA for TScan sponsored clinical treatment study(s). No treatment intervention will occur as part of this screening study. Participants will be required to provide a buccal swab to assess their HLA status. If they are positive for certain types of HLA, participants will provide 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 subsequent visit. If eligible, participants will be referred to appropriate available interventional trial(s) at the discretion of the Investigator.

Study Type : OBSERVATIONAL
Estimated Enrollment : 650 participants
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
Actual Study Start Date : 2023-06-26
Estimated Primary Completion Date : 2026-01-01
Estimated Study Completion Date : 2027-01-14

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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:
  • * Head and neck cancer
  • * Cervical cancer
  • * Non-small cell lung cancer
  • * Melanoma
  • * Ovarian cancer
  • * HPV positive anogenital cancers
  • * 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 FFPE tumor block that is \<8 months old or is willing to provide a fresh core-needle biopsy.
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.
A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors

Location Details

NCT05812027

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

HonorHealth Research and Innovation Institute

Scottsdale, Arizona, United States, 85258

RECRUITING

United States, California

University of California San Diego

San Diego, California, United States, 92037

RECRUITING

United States, Connecticut

Yale Cancer Center

New Haven, Connecticut, United States, 06510

RECRUITING

United States, Florida

Memorial Healthcare System

Hollywood, Florida, United States, 33021

RECRUITING

United States, Florida

University of Miami, Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136

RECRUITING

United States, Florida

Orlando Health

Orlando, Florida, United States, 32806

RECRUITING

United States, Florida

University of South Florida

Tampa, Florida, United States, 33606

RECRUITING

United States, Kentucky

Norton Cancer Institute

Louisville, Kentucky, United States, 40202

RECRUITING

United States, Road cancer

Karmanos Cancer Institute

Detroit, Road cancer, United States, 48201

RECRUITING

United States, Minnesota

University of Minnesota, Masonic Cancer Center

Minneapolis, Minnesota, United States, 55455

RECRUITING

United States, New York

Columbia University Herbert Irving Comprehensive Cancer Center

New York, New York, United States, 10032

RECRUITING

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

RECRUITING

United States, Ohio

The Cleveland Clinic

Cleveland, Ohio, United States, 44195

RECRUITING

United States, Oklahola

OU Health Stephenson Cancer Center

Ololama City, Okholohan, United States, 73104

RECRUITING

United States, Oregon

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States, 97213

RECRUITING

United States, Pennsylvania

Allegheny Hospitals Network

Pittsburgh, Pennsylvania, United States, 15224

RECRUITING

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15232

RECRUITING

United States, Tennessee

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203