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

StatusActive, Not Recruiting
PhaseNot specified
Started2023-06-26
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 17, 2025 (before its estimated January 1, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-11-14
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v20
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 21 of 21 sites
2025-06-20
Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v19
Enrollment target650→1150
Study sites18→21
Eligibility criteria+105 characters
[...] ed 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 Melanoma Ovarian cancer HPV positive anogenital cancers Sarcoma Other cancers with a reasonable likelihood of expressing 1 o [...] 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. Exclusion Criteria: • Participants undergoing anticancer t [...]
Study description-104 characters
This multicenter screening study will be conducted to determine a participant's tumor-associated antigen expression profile, HLA genotypetypes and loss of HLA heterozygosity status for potential enrollment in a TScan sponsored clinical treatment study(s). No treatment intervention will occur as part of this scree [...] ll be required to provide a buccal swab to assess their HLA status. If they are positive for certain types ofand HLA, participants will providea saliva sample to assess for HLA loss of heterozygosity. InFor parallelparticipants with an HLA type for which TScan has an open clinical stud [...] [...]
2025-03-28
Study Status, Study Description, Conditions, Outcome Measures, Contacts/Locations v18
Study sites15→18
Study description+22 characters
This multicenter screening study will be conducted to determine a subjectparticipant's tumor antigen expression profile, HLA genotype and loss of HLA LOH for TScan sponsored clinical treatment study(s). No treatment intervention will occur as part of this screening study. SubjectsParticipants will be required to provide a buccal swab to assess their HLA status. If they are positive for certain types of HLA, subjectsparticipants will provide a saliva sample to assess HLA loss of heterozygosity. In para [...] s, a fresh tumor biopsy will be required at the time of the secondsubsequent visit. If eligibl [...] [...]
2024-08-22
Study Status, Contacts/Locations v17
Study sites14→15
2024-08-12
Study Status, Contacts/Locations v16
Re-verified, no change to tracked fields
Show 15 earlier versions
2024-04-24
Study Status, Contacts/Locations v15
Study sitescontacts updated at 1 of 14 sites
2024-04-19
Study Status, Study Description, Conditions, Outcome Measures, Eligibility, Contacts/Locations v14
Eligibility criteria+179 characters
[...] cer 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 [...] r the LOH assay Have access to an FFPE tumor block that is <68 months old or is willing to provide a fresh core-needle bio [...]
Study description-31 characters
[...] HLA status. If they are positive for certain types of HLA, theysubjects will return for a subsequent visit to provide a saliva sample to assess HLA loss of heterozygosity. In parallel, archival tissue (less than 68 months old) will be needed to assess for tumor antigen expression. If archival tissue is older than six8 months, a fresh tumor biopsy will be required at the time o [...]
2024-04-05
Study Status, Contacts/Locations v13
Study sitescontacts updated at 2 of 14 sites
2024-03-20
Study Status, Contacts/Locations v12
Study sites13→14
2024-02-26
Study Status, Contacts/Locations v11
Study sites12→13
2024-01-10
Study Status, Study Design, Contacts/Locations v10
Enrollment target200→650
Study sitescontacts updated at 1 of 12 sites
2024-01-09
Study Status, Contacts/Locations v9
Study sites10→12
2024-01-07
Study Status, Contacts/Locations v8
Study sites6→10
2023-11-14
Study Status, Conditions, Contacts/Locations v7
Study sitescontacts updated at 1 of 6 sites
2023-10-26
Study Status, Contacts/Locations v6
Study sites4→6
2023-09-07
Study Status, Contacts/Locations v5
Study sites3→4
2023-08-22
Study Status, Conditions, Study Design v4
Re-verified, no change to tracked fields
2023-08-21
Study Status, Conditions, Contacts/Locations v3
Study sites2→3
2023-06-27
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-06-14→confirmed 2023-06-26
Study sites1→2
2023-06-09
Study Status, Study Description, Conditions, Eligibility, Contacts/Locations v1
Start date2023-05-01→2023-06-14
Study sites0→1
Eligibility criteria-1 characters
[...] to provide a fresh core-needle biopsy. Exclusion Criteria: 1.• Participants undergoing anticancer therapy with curative in [...]
2023-03-31
Original filing
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.
Trial Details
NCT Number NCT05812027
Lead Sponsor TScan Therapeutics, Inc.
Conditions Head and Neck Cancer, Cervical Cancer, Non Small Cell Lung Cancer, HPV16 Related Cancers, Sarcoma, Uveal Melanoma, NUT Carcinoma
Enrollment 1,150 participants
Start Date 2023-06-26
Primary Completion 2026-01-01 (estimated)
Study Completion 2027-01-14 (estimated)
Updated on ClinicalTrials.gov 2025-11-17