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

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ClinicalTrials.gov Identifier: NCT05812027
Recruitment Status : Recruiting
First Posted : April 13, 2023
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
TScan Therapeutics, Inc.

Tracking Information
First Submitted Date March 31, 2023
First Posted Date April 13, 2023
Last Update Posted Date April 25, 2024
Actual Study Start Date June 26, 2023
Estimated Primary Completion Date January 1, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 19, 2024)		 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 HPV positive anogenital and other types of cancers that could potentially be eligible for the TScan Therapeutics clinical trials.
Original Primary Outcome Measures
 (submitted: March 31, 2023)		 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.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Diagnostic Test: Tumor Profiling for TAA expression, HLA typing and HLA loss.
Sampling Method Non-Probability Sample
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).
Condition
  • Head and Neck Cancer
  • Cervical Cancer
  • Non Small Cell Lung Cancer
  • Melanoma
  • Ovarian Cancer
  • HPV16 Related Cancers
Intervention Diagnostic Test: Tumor and HLA Profiling
HLA genotyping and tumor tissue profiling for certain TAA and LOH.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 10, 2024)		 650
Original Estimated Enrollment
 (submitted: March 31, 2023)		 200
Estimated Study Completion Date January 14, 2027
Estimated Primary Completion Date January 1, 2026   (Final data collection date for primary outcome measure)
Eligibility 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
  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Marlyane Motta, BS 857 399-9887 mmotta@tscan.com
Contact: OncoBay Clinical CRO 843-321-8490 oncobaysites@oncobay.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05812027
Other Study ID Numbers TSCAN-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party TScan Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor TScan Therapeutics, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Dawn Pinchasik, MD TScan Therapeutics, Inc.
PRS Account TScan Therapeutics, Inc.
Verification Date April 2024