ClinicalTrials.gov
History of Changes for Study: NCT05812027
A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors
Latest version (submitted April 24, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 31, 2023 None (earliest Version on record)
2 June 9, 2023 Conditions, Study Status, Contacts/Locations, Eligibility and Study Description
3 June 27, 2023 Recruitment Status, Study Status and Contacts/Locations
4 August 21, 2023 Study Status, Contacts/Locations and Conditions
5 August 22, 2023 Study Design, Conditions and Study Status
6 September 7, 2023 Contacts/Locations and Study Status
7 October 26, 2023 Study Status and Contacts/Locations
8 November 14, 2023 Contacts/Locations, Conditions and Study Status
9 January 7, 2024 Study Status and Contacts/Locations
10 January 9, 2024 Contacts/Locations and Study Status
11 January 10, 2024 Contacts/Locations, Study Design and Study Status
12 February 26, 2024 Study Status and Contacts/Locations
13 March 20, 2024 Contacts/Locations and Study Status
14 April 5, 2024 Contacts/Locations and Study Status
15 April 19, 2024 Contacts/Locations, Eligibility, Outcome Measures, Conditions, Study Description and Study Status
16 April 24, 2024 Contacts/Locations and Study Status
Comparison Format:
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Changes (Merged) for Study: NCT05812027
March 31, 2023 (v1) -- January 10, 2024 (v11)

Changes in: Study Status, Study Description, Conditions, Study Design, Eligibility and Contacts/Locations
Open or close this module Study Identification
Unique Protocol ID: TSCAN-003
Brief Title: A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors
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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2023 January 2024
Overall Status: Not yet recruiting Recruiting
Study Start: May 1 June 26, 2023
Primary Completion: January 1, 2026 [Anticipated]
Study Completion: January 14, 2027 [Anticipated]
First Submitted: March 31, 2023
First Submitted that
Met QC Criteria:		 March 31, 2023
First Posted: April 13, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:		 March 31, 2023 January 10, 2024
Last Update Posted: April 13 January 11, 2023 2024 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: TScan Therapeutics, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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 Human Leukocyte Antigen (HLA) molecules. The purpose of this screening study is to collect samples to conduct HLA genotyping, HLA LOH Loss of Heterozygosity (LOH) and expression of tumor antigens 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, 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.
Open or close this module Conditions
Conditions: Head and Neck Cancer
Cervical Cancer
Non Small Cell Lung Cancer
Melanoma
Ovarian Cancer
HPV16 Related Cancers
HPV
Adenocarcinoma
Squamous Cell Carcinoma
Epithelial Carcinoma
Keywords: Loss of Heterozygosity
HLA
TAA
MAGE-A1
Adenocarcinoma
Squamous Cell Carcinoma
Epithelial Carcinoma
HPV Positive Cancers
TScan Therapeutics
TSCAN-002
TSCAN-003
PRAME
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Only
Time Perspective: Retrospective Prospective
Biospecimen Retention: Samples With DNA
Biospecimen Description: Diagnostic Test: Tumor Profiling for TAA expression, HLA typing and HLA loss.
Enrollment: 200 650 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Intervention Details:
Diagnostic Test: Tumor and HLA Profiling
HLA genotyping and tumor tissue profiling for certain TAA and LOH.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Frequency of subjects with TAA expression, HLA typing and HLA loss.
[ Time Frame: 3 years ]

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.
Open or close this module Eligibility
Study Population: The purpose of this study is to identify participants with locally advanced (unresectable) or metastatic solid tumors that could potentially be eligible for a TScan treatment clinical trial(s).
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
  • 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.
  • 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:

1. • 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.
Open or close this module Contacts/Locations
Central Contact Person: Marlyane Motta, BS
Telephone: 857-399-9887
Email: mmotta@tscan.com
Central Contact Backup: OncoBay Clinical CRO
Telephone: 843-321-8490
Email: oncobaysites@oncobay.com
Study Officials: Debora Barton, MD
Study Director
TScan Therapeutics, Inc.
Locations: United States, Arizona
HonorHealth Research and Innovation Institute
[Recruiting]
Scottsdale, Arizona, United States, 85258
Contact:Contact: Justin Moser, MD 480-323-1364 clinicaltrials@honorhealth.com
United States, Connecticut
Yale Cancer Center
[Recruiting]
New Haven, Connecticut, United States, 06510
Contact:Contact: Jialing Zhang 475-234-9684 Jialing.zhang@yale.edu
Contact:Principal Investigator: Michael Hurwitz, MD
United States, Florida
Memorial Healthcare System
[Recruiting]
Hollywood, Florida, United States, 33021
Contact:Contact: Brian Pico, MD 954-265-1847 bpico@mhs.net
Orlando Health
[Recruiting]
Orlando, Florida, United States, 32806
Contact:Contact: Melinda Porter 321-841-7246 janice.porter@orlandohealth.com
Contact:Principal Investigator: Sajeve Thomas, MD
United States, Kentucky
Norton Cancer Institute
[Recruiting]
Louisville, Kentucky, United States, 40202
Contact:Contact: Ben Orem 502-629-2500 Ext. 19471 ben.orem@nortonhealthcare.org
Contact:Principal Investigator: Jaspreet Grewal, MD
United States, Minnesota
University of Minnesota, Masonic Cancer Center
[Recruiting]
Minneapolis, Minnesota, United States, 55455
Contact:Contact: Manar Al-Assi malassi@umn.edu
United States, New York
Columbia University Herbert Irving Comprehensive Cancer Center
[Recruiting]
New York, New York, United States, 10032
Contact:Contact: Elizabeth Shelton, MPH cancerclinicaltrials@cumc.columbia.edu
Contact:Principal Investigator: Brian Henick, MD
United States, North Carolina
University of North Carolina at Chapel Hill
[Recruiting]
Chapel Hill, North Carolina, United States, 27599
Contact:Contact: Jared Weiss, MD
United States, Ohio
The Cleveland Clinic
[Recruiting]
Cleveland, Ohio, United States, 44195
Contact:Contact: Sarah Kabalan 866-223-8100 kabalas@ccf.org
Contact:Principal Investigator: James Isaacs, MD
United States, Oregon
Providence Cancer Institute Franz Clinic
[Recruiting]
Portland, Oregon, United States, 97213
Contact:Contact: Rom Leidner, MD 503-215-2614 CanRsrchStudies@providence.org
Contact:Principal Investigator: Rom Leidner, MD
United States, Pennsylvania
Allegheny Hospitals Network
[Recruiting]
Pittsburgh, Pennsylvania, United States, 15224
Contact:Contact: Shelly Evans shelly.evans@ahn.org
Contact:Principal Investigator: Yazan Samhouri, MD
University of Pittsburgh Medical Center
[Recruiting]
Pittsburgh, Pennsylvania, United States, 15232
Contact:Contact: Barb Stadterman stadtermanbm@upmc.edu
Contact:Principal Investigator: Jason Luke, MD
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services