IRB Study Number 23-890
Status Recruiting
Institute Taussig Cancer Institute
Description
4.1. Primary Objective
To identify participants with locally advanced (unresectable) or metastatic solid tumors that could potentially be eligible for a TScan treatment study.
4.2. Exploratory Objective
To assess the prevalence of HLA types and tumor antigen expression in participants with locally advanced (unresectable) or metastatic solid tumors.
Inclusion Criteria
Willing and able to provide written informed consent. Decision-impaired adults may consent with their legally authorized representative.
Male or female aged ≥18 years at the time of signing the informed consent.
Have a histologically or cytologically confirmed locally advanced (unresectable) or metastatic solid tumor for which the Sponsor has an associated clinical study. Patients with the following solid tumors may participate in this screening study without prior approval of the Sponsor:
• Head and neck cancer
• Cervical cancer
• Non-small cell lung cancer
• HPV+ anogenital cancers
• Sarcoma
Patients with other cancer types that have a reasonable likelihood of expressing 1 or more antigens included in a TScan clinical study may become eligible to participate in this screening study, following approval from the Sponsor.
Willing to provide a buccal swab for HLA testing.
Willing to provide a saliva sample or, if necessary based on tumor location, a blood sample to use as a normal control for the HLA LOH assay.
Have access to an adequate FFPE tumor block that is ≤8 months old or is willing to provide a fresh biopsy from a location deemed safe by the treating medical team.
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 advanced disease and are expected to have a high risk of relapse after their curative intent therapy, as determined by the treating Investigator.
