Head and Neck CancerNCT05812027
A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors
An observational study of Head and Neck Cancer and Cervical Cancer, run by TScan Therapeutics, Inc. at 21 sites in United States.
Trial summary
TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous T cells are engineered to express a T cell receptor that recognizes tumor-associated antigens presented on specific Human Leukocyte Antigen (HLA) molecules. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Cervical Cancer, Non Small Cell Lung Cancer
- What is being tested?
- Tumor and HLA Profiling
- How many people
- 1,150 participants
- Where
- 21 sitesUnited States
- Study dates
- 26 Jun 2023to 14 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 clinical study.
Who may be able to join
- 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 for which the Sponsor has an associated clinical study:
- Head and neck cancer
- Cervical cancer
- Non-small cell lung cancer
Show all 12Show fewer
- HPV positive anogenital cancers
- Sarcoma
- 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 adequate FFPE tumor block that is <8 months old or is willing to provide a fresh core-needle biopsy from a location deemed safe by the treating medical team.
Who cannot join
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
University of Chicago
Chicago, Illinois, 60637
Oncology Hematology Care
Cincinnati, Ohio, 45242
The Cleveland Clinic
Cleveland, Ohio, 44195
Karmanos Cancer Institute
Detroit, Michigan, 48201
Memorial Healthcare System
Hollywood, Florida, 33021
Baylor College of Medicine
Houston, Texas, 77030
Norton Cancer Institute
Louisville, Kentucky, 40202
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
University of Minnesota, Masonic Cancer Center
Minneapolis, Minnesota, 55455
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Yale Cancer Center
New Haven, Connecticut, 06510
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Orlando Health
Orlando, Florida, 32806
Allegheny Hospitals Network
Pittsburgh, Pennsylvania, 15224
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
University of California San Diego
San Diego, California, 92037
HonorHealth Research and Innovation Institute
Scottsdale, Arizona, 85258
University of South Florida
Tampa, Florida, 33606
About this study
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
TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous T cells are engineered to express a T cell receptor that recognizes tumor-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) assessment, and expression of Tumor-associated Antigens (TAA) testing. These results will be used to determine if participants meet the eligibility criteria for these parameters and could potentially be enrolled in a TScan clinical study.
Read the detailed description
This multicenter screening study will be conducted to determine a participant's tumor-associated antigen expression, HLA types and loss of HLA heterozygosity status for potential enrollment in a TScan sponsored clinical study. No treatment intervention will occur as part of this screening study.
Participants will be required to provide a buccal swab to assess their HLA types and a saliva sample to assess for HLA loss of heterozygosity. For participants with an HLA type for which TScan has an open clinical study, archival tissue (less than 8 months old) will be needed to assess for tumor-associated antigen expression. If archival tissue is not available or older than 8 months, a fresh tumor biopsy will be required.
- Conditions
- Head and Neck Cancer, Cervical Cancer, Non Small Cell Lung Cancer, HPV16 Related Cancers, Sarcoma, Uveal Melanoma
- Being tested
- Tumor and HLA Profiling
- Keywords
- Loss of Heterozygosity, HLA, Carcinoma, MAGE-A1, Adenocarcinoma, Squamous Cell Carcinoma, Epithelial Carcinoma, HPV Positive Cancers, TScan Therapeutics, TSCAN-002, TSCAN-003, PRAME, MAGE-C2, MAGE-A4, Sarcoma, Human Papillomavirus, Solid Tumor, HPV Positive Anogenital Cancer
- Medical subject headings
- Head and Neck Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Non-Small-Cell Lung, Sarcoma, Uveal Melanoma, Carcinoma, Adenocarcinoma, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor and HLA ProfilingDiagnostic test
HLA genotyping and tumor tissue profiling for certain tumor-associated antigens and HLA LOH.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of subjects with TAA expression, HLA typing and HLA loss.
To identify participants that could potentially be eligible for the TScan Therapeutics clinical trials.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start26 Jun 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion14 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TScan Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dawn Pinchasik, MD, Study director, TScan Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812027
- Sponsor's protocol ID
- TSCAN-003
- Status last verified
- Nov 2025
- First submitted
- 31 Mar 2023
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05812027
- Acronym / sponsor ID
- TSCAN-003
- Conditions
- Head and Neck Cancer, Cervical Cancer, Non Small Cell Lung Cancer, HPV16 Related Cancers, Sarcoma, Uveal Melanoma
- Keywords
- Loss of Heterozygosity, HLA, Carcinoma, MAGE-A1, Adenocarcinoma, Squamous Cell Carcinoma, Epithelial Carcinoma, HPV Positive Cancers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,150 participants (estimated)
- Lead sponsor
- TScan Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 14 Jan 2027 (estimated)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous T cells are engineered to express a T cell receptor that recognizes tumor-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) assessment, and expression of Tumor-associated Antigens (TAA) testing. These results will be used to determine if participants meet the eligibility criteria for these parameters and could potentially be enrolled in a TScan clinical study.
Detailed description
This multicenter screening study will be conducted to determine a participant's tumor-associated antigen expression, HLA types and loss of HLA heterozygosity status for potential enrollment in a TScan sponsored clinical study. No treatment intervention will occur as part of this screening study.
Participants will be required to provide a buccal swab to assess their HLA types and a saliva sample to assess for HLA loss of heterozygosity. For participants with an HLA type for which TScan has an open clinical study, archival tissue (less than 8 months old) will be needed to assess for tumor-associated antigen expression. If archival tissue is not available or older than 8 months, a fresh tumor biopsy will be required.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 clinical study.
Key inclusion criteria (12 listed)
- 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 for which the Sponsor has an associated clinical study:
- Head and neck cancer
- Cervical cancer
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor and HLA ProfilingHLA genotyping and tumor tissue profiling for certain tumor-associated antigens and HLA LOH. | Diagnostic test | – |
Primary outcome
Frequency of subjects with TAA expression, HLA typing and HLA loss.
Time frame: 3 years
To identify participants that could potentially be eligible for the TScan Therapeutics clinical trials.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Pinchasik, MD study director
TScan Therapeutics, Inc.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Cervical Cancer, run by TScan Therapeutics, Inc. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of subjects with TAA expression, HLA typing and HLA loss. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.