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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05812027
• Other study ID #: TSCAN-003
• Status: Recruiting
• Start date: June 26, 2023
• Est. completion date: January 14, 2027

Study information

• Verified date: April 2024
• Source: TScan Therapeutics, Inc.
• Contact: Marlyane Motta, BS
• Phone: 857 399-9887
• Email: mmotta[@]tscan.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: January 14, 2027
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Head and Neck Cancer
• Melanoma
• Non Small Cell Lung Cancer
• Ovarian Cancer

Intervention

Diagnostic Test:
• Tumor and HLA Profiling
HLA genotyping and tumor tissue profiling for certain TAA and LOH.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	The Cleveland Clinic	Cleveland	Ohio
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Memorial Healthcare System	Hollywood	Florida
United States	Norton Cancer Institute	Louisville	Kentucky
United States	University of Miami, Sylvester Comprehensive Cancer Center	Miami	Florida
United States	University of Minnesota, Masonic Cancer Center	Minneapolis	Minnesota
United States	Yale Cancer Center	New Haven	Connecticut
United States	Columbia University Herbert Irving Comprehensive Cancer Center	New York	New York
United States	Orlando Health	Orlando	Florida
United States	Allegheny Hospitals Network	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Providence Cancer Institute Franz Clinic	Portland	Oregon
United States	HonorHealth Research and Innovation Institute	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
TScan Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 HPV positive anogenital and other types of cancers that could potentially be eligible for the TScan Therapeutics clinical trials.	3 years