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

Study Overview
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Brief Summary
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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 subjects meet the eligibility criteria for these parameters and could potentially be enrolled in a TScan clinical treatment study.

Detailed Description
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This multicenter screening study will be conducted to determine a subject's tumor antigen expression profile, HLA genotype and HLA LOH for TScan sponsored clinical treatment study(s). No treatment intervention will occur as part of this screening study. Subjects will be required to provide a buccal swab to assess their HLA status. If they are positive for certain types of HLA, they will return for a subsequent visit to provide a saliva sample to assess HLA loss of heterozygosity. In parallel, archival tissue (less than 6 months old) will be needed to assess for tumor antigen expression. If archival tissue is older than six months, a fresh tumor biopsy will be required at the time of the second visit. If eligible, subjects will be referred to appropriate available interventional trial(s) at the discretion of the Investigator.

Official Title
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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

Conditions
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Head and Neck Cancer, Cervical Cancer, Non Small Cell Lung Cancer, Melanoma, Ovarian Cancer, HPV16 Related Cancers

Intervention / Treatment
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* Diagnostic Test: Tumor and HLA Profiling


Participation Criteria
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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: Head and neck cancer Cervical cancer Non-small cell lung cancer Melanoma Ovarian cancer HPV positive anogenital cancers 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 <6 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Tumor and HLA Profiling|HLA genotyping and tumor tissue profiling for certain TAA and LOH.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of subjects with TAA expression, HLA typing and HLA loss. | To identify subjects with Head and Neck, Cervical, Ovarian, Melanoma, Non-Small Cell Lung and HPV positive anogenital cancers that could potentially be eligible for the TScan Therapeutics clinical trials. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HLA, Loss of Heterozygosity, TAA, MAGE-A1, Adenocarcinoma, Squamous Cell Carcinoma, Epithelial Carcinoma, HPV Positive Cancers, TScan Therapeutics, TSCAN-002, TSCAN-003, PRAME