A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors
a study on Head and Neck Cancer Cervical Cancer Lung Cancer Non-Small Cell Lung Cancer Cancer, General Human Papillomavirus Sarcoma Ocular Melanoma Skin Cancer/Melanoma NUT Carcinoma Solid Tumor Head and Neck Tumor Carcinoma Squamous Cell Carcinoma
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCSD
- Dates
- study startedstudy ends around
Description
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.
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
Details
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.
Keywords
Head and Neck Cancer, Cervical Cancer, Non Small Cell Lung Cancer, HPV16 Related Cancers, Sarcoma, Uveal Melanoma, NUT Carcinoma, Loss of Heterozygosity, HLA, Carcinoma, MAGE-A1, Adenocarcinoma, Squamous Cell Carcinoma, Epithelial Carcinoma, HPV Positive Cancers, TScan Therapeutics, TSCAN-002, TSCAN-003, PRAME, MAGE-C2, MAGE-A4, Human Papillomavirus, Solid Tumor, HPV Positive Anogenital Cancer, Head and Neck Neoplasms, Uterine Cervical Neoplasms, Non-Small-Cell Lung Carcinoma, Tumor and HLA Profiling
Eligibility
You can join if…
Open to people ages 18 years and up
- 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 CAN'T join 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.
Locations
- University of California San Diego
San Diego California 92037 United States - HonorHealth Research and Innovation Institute
Scottsdale Arizona 85258 United States
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- TScan Therapeutics, Inc.
- ID
- NCT05812027
- Study Type
- Observational
- Participants
- Expecting 1150 study participants
- Last Updated