Trial Title:
A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors
NCT ID:
NCT05812027
Condition:
Head and Neck Cancer
Cervical Cancer
Non Small Cell Lung Cancer
Melanoma
Ovarian Cancer
HPV16 Related Cancers
Conditions: 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
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Tumor and HLA Profiling
Description:
HLA genotyping and tumor tissue profiling for certain TAA and LOH.
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 subjects 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 subject's tumor antigen
expression profile, HLA genotype and HLA LOH for TScan sponsored clinical treatment
study(s). No treatment intervention will occur as part of this screening study.
Subjects will be required to provide a buccal swab to assess their HLA status. If they
are positive for certain types of HLA, subjects will provide a 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 second visit.
If eligible, subjects will be referred to appropriate available interventional trial(s)
at the discretion of the Investigator.
Criteria for eligibility:
Study pop:
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).
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
HonorHealth Research and Innovation Institute
Address:
City:
Scottsdale
Zip:
85258
Country:
United States
Status:
Recruiting
Contact:
Last name:
Justin Moser, MD
Phone:
480-323-1364
Email:
clinicaltrials@honorhealth.com
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jialing Zhang
Phone:
475-234-9684
Email:
Jialing.zhang@yale.edu
Investigator:
Last name:
Michael Hurwitz, MD
Email:
Principal Investigator
Facility:
Name:
Memorial Healthcare System
Address:
City:
Hollywood
Zip:
33021
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Pico, MD
Phone:
954-265-1847
Email:
bpico@mhs.net
Facility:
Name:
University of Miami, Sylvester Comprehensive Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marialby Donis Ramos
Phone:
305-243-1000
Email:
mxd4514@med.miami.edu
Investigator:
Last name:
Jose Lutzky, MD
Email:
Principal Investigator
Facility:
Name:
Orlando Health
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melinda Porter
Phone:
321-841-7246
Email:
janice.porter@orlandohealth.com
Investigator:
Last name:
Sajeve Thomas, MD
Email:
Principal Investigator
Facility:
Name:
Norton Cancer Institute
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ben Orem
Phone:
502-629-2500
Phone ext:
19471
Email:
ben.orem@nortonhealthcare.org
Investigator:
Last name:
Jaspreet Grewal, MD
Email:
Principal Investigator
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marie Ventimiglia
Phone:
313-576-9271
Email:
ventimim@karmanos.org
Investigator:
Last name:
Ira Winer, MD
Email:
Principal Investigator
Facility:
Name:
University of Minnesota, Masonic Cancer Center
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Recruiting
Contact:
Last name:
Manar Al-Assi
Email:
malassi@umn.edu
Facility:
Name:
Columbia University Herbert Irving Comprehensive Cancer Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elizabeth Shelton, MPH
Email:
cancerclinicaltrials@cumc.columbia.edu
Investigator:
Last name:
Brian Henick, MD
Email:
Principal Investigator
Facility:
Name:
University of North Carolina at Chapel Hill
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
UNC Immunotherapy Team
Phone:
919-445-4208
Email:
UNCImmunotherapy@med.unc.edu
Investigator:
Last name:
Jared Weiss, MD
Email:
Principal Investigator
Facility:
Name:
The Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cancer Answer Line
Phone:
216-444-7923
Investigator:
Last name:
James Isaacs, MD
Email:
Principal Investigator
Facility:
Name:
OU Health Stephenson Cancer Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cynthia Lowery
Email:
Cynthia-Lowery@ouhsc.edu
Investigator:
Last name:
Manu Pandey, MD
Email:
Principal Investigator
Facility:
Name:
Providence Cancer Institute Franz Clinic
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rom Leidner, MD
Phone:
503-215-2614
Email:
CanRsrchStudies@providence.org
Investigator:
Last name:
Rom Leidner, MD
Email:
Principal Investigator
Facility:
Name:
Allegheny Hospitals Network
Address:
City:
Pittsburgh
Zip:
15224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shelly Evans
Email:
shelly.evans@ahn.org
Investigator:
Last name:
Yazan Samhouri, MD
Email:
Principal Investigator
Facility:
Name:
University of Pittsburgh Medical Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Barb Stadterman
Email:
stadtermanbm@upmc.edu
Investigator:
Last name:
Jason Luke, MD
Email:
Principal Investigator
Start date:
June 26, 2023
Completion date:
January 14, 2027
Lead sponsor:
Agency:
TScan Therapeutics, Inc.
Agency class:
Industry
Source:
TScan Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05812027
