Clinical trial NCT05812027: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Cervical Cancer
Non Small Cell Lung Cancer
Melanoma
Ovarian Cancer
HPV16 Related Cancers
Keywords: Loss of Heterozygosity
HLA
TAA
MAGE-A1
Adenocarcinoma
Squamous Cell Carcinoma
Epithelial Carcinoma
HPV Positive Cancers
TScan Therapeutics
TSCAN-002
TSCAN-003
PRAME
MAGE-C2
MAGE-A4
Lead sponsor: TScan Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-13
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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 participants 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 participant's tumor antigen expression profile, HLA genotype and loss of HLA for TScan sponsored clinical treatment study(s). No treatment intervention will occur as part of this screening study.

Participants will be required to provide a buccal swab to assess their HLA status. If they are positive for certain types of HLA, participants will provide 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 subsequent visit.

If eligible, participants will be referred to appropriate available interventional trial(s) at the discretion of the Investigator.

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.

Primary outcomes:
measure: Frequency of subjects with TAA expression, HLA typing and HLA loss.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research and Innovation Institute
state: Arizona
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Miami
country: United States
facility: University of Miami, Sylvester Comprehensive Cancer Center
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota, Masonic Cancer Center
state: Minnesota
city: New York
country: United States
facility: Columbia University Herbert Irving Comprehensive Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: OU Health Stephenson Cancer Center
state: Oklahoma
city: Portland
country: United States
facility: Providence Cancer Institute Franz Clinic
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny Hospitals Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
Study officials:
affiliation: TScan Therapeutics, Inc.
name: Dawn Pinchasik, MD
role: STUDY_DIRECTOR
References: