Screening patients with metastatic solid tumors for HLA and tumor antigen testing
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
This study is testing whether patients with metastatic solid tumors can provide samples to see if they qualify for future treatments that target specific cancer-related markers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 650 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | TScan Therapeutics, Inc. Industry-sponsored |
| Locations | 18 sites (Scottsdale, Arizona and 17 other locations) |
| Trial ID | NCT05812027 on ClinicalTrials.gov |
What this trial studies
This observational screening study aims to collect samples from patients with metastatic solid tumors to assess their HLA genotype, loss of heterozygosity, and tumor-associated antigen expression. Participants will provide a buccal swab for HLA testing and may need to submit saliva and archival tissue samples for further analysis. The results will help determine eligibility for future TScan clinical treatment studies targeting specific cancer-associated antigens. No treatment will be administered during this screening phase.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed metastatic solid tumors such as head and neck cancer, cervical cancer, non-small cell lung cancer, melanoma, or ovarian cancer.
Not a fit: Patients currently undergoing anticancer therapy with curative intent or those without accessible tumor samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients who are eligible for innovative cellular therapies targeting their specific cancer types.
How similar studies have performed: Other studies utilizing HLA profiling and tumor antigen testing have shown promise in identifying suitable candidates for targeted therapies, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Scottsdale, Arizona and 17 other locations
- HonorHealth Research and Innovation Institute — Scottsdale, Arizona, United States (Recruiting)
- University of California San Diego — San Diego, California, United States (Recruiting)
- Yale Cancer Center — New Haven, Connecticut, United States (Recruiting)
- Memorial Healthcare System — Hollywood, Florida, United States (Recruiting)
- University of Miami, Sylvester Comprehensive Cancer Center — Miami, Florida, United States (Recruiting)
- Orlando Health — Orlando, Florida, United States (Recruiting)
- University of South Florida — Tampa, Florida, United States (Recruiting)
- Norton Cancer Institute — Louisville, Kentucky, United States (Recruiting)
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- University of Minnesota, Masonic Cancer Center — Minneapolis, Minnesota, United States (Recruiting)
- Columbia University Herbert Irving Comprehensive Cancer Center — New York, New York, United States (Recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- The Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (Recruiting)
- Providence Cancer Institute Franz Clinic — Portland, Oregon, United States (Recruiting)
- Allegheny Hospitals Network — Pittsburgh, Pennsylvania, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Erica Gagnon
- Email: medicalaffairs@tscan.com
- Phone: 857-399-9887
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.