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

Recruiting

• Conditions: Cervical Cancer; Ovarian Cancer; Melanoma; Head and Neck Cancer; Non Small Cell Lung Cancer; HPV16 Related Cancers

• Registration Number: NCT05812027
• Lead 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 subjects meet the eligibility criteria for these parameters and could potentially be enrolled in a TScan clinical treatment study.

Detailed Description

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, subjects will provide a 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 second visit.

If eligible, subjects will be referred to appropriate available interventional trial(s) at the discretion of the Investigator.

Study Timeline

• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Study First Posted: 2023-04-13
• Study Start: 2023-06-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26
• Primary Completion: 2026-01-01
• Study Completion: 2027-01-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (15)

The Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University of Miami, Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

OU Health Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Providence Cancer Institute Franz Clinic; 🇺🇸 Portland, Oregon, United States

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Orlando Health; 🇺🇸 Orlando, Florida, United States

Norton Cancer Institute; 🇺🇸 Louisville, Kentucky, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Allegheny Hospitals Network; 🇺🇸 Pittsburgh, Pennsylvania, United States

Memorial Healthcare System; 🇺🇸 Hollywood, Florida, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Minnesota, Masonic Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States

Columbia University Herbert Irving Comprehensive Cancer Center; 🇺🇸 New York, New York, United States

HonorHealth Research and Innovation Institute; 🇺🇸 Scottsdale, Arizona, United States