A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors
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| ClinicalTrials.gov Identifier: NCT05812027 |
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Recruitment Status :
Recruiting
First Posted : April 13, 2023
Last Update Posted : April 25, 2024
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Sponsor:
TScan Therapeutics, Inc.
Information provided by (Responsible Party):
TScan Therapeutics, Inc.
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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 subjects meet the eligibility criteria for these parameters and could potentially be enrolled in a TScan clinical treatment study.
| Condition or disease | Intervention/treatment |
|---|---|
| Head and Neck Cancer Cervical Cancer Non Small Cell Lung Cancer Melanoma Ovarian Cancer HPV16 Related Cancers | Diagnostic Test: Tumor and HLA Profiling |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 650 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| 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 |
| Actual Study Start Date : | June 26, 2023 |
| Estimated Primary Completion Date : | January 1, 2026 |
| Estimated Study Completion Date : | January 14, 2027 |
Resource links provided by the National Library of Medicine
Intervention Details:
- Diagnostic Test: Tumor and HLA Profiling
HLA genotyping and tumor tissue profiling for certain TAA and LOH.
Primary Outcome Measures :
- Frequency of subjects with TAA expression, HLA typing and HLA loss. [ Time Frame: 3 years ]To identify subjects with Head and Neck, Cervical, Ovarian, Melanoma, Non-Small Cell Lung HPV positive anogenital and other types of cancers that could potentially be eligible for the TScan Therapeutics clinical trials.
Biospecimen Retention: Samples With DNA
Diagnostic Test: Tumor Profiling for TAA expression, HLA typing and HLA loss.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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).
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05812027
Contacts
| Contact: Marlyane Motta, BS | 857 399-9887 | mmotta@tscan.com | |
| Contact: OncoBay Clinical CRO | 843-321-8490 | oncobaysites@oncobay.com |
Locations
| United States, Arizona | |
| HonorHealth Research and Innovation Institute | Recruiting |
| Scottsdale, Arizona, United States, 85258 | |
| Contact: Justin Moser, MD 480-323-1364 clinicaltrials@honorhealth.com | |
| United States, Connecticut | |
| Yale Cancer Center | Recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Contact: Jialing Zhang 475-234-9684 Jialing.zhang@yale.edu | |
| Principal Investigator: Michael Hurwitz, MD | |
| United States, Florida | |
| Memorial Healthcare System | Recruiting |
| Hollywood, Florida, United States, 33021 | |
| Contact: Brian Pico, MD 954-265-1847 bpico@mhs.net | |
| University of Miami, Sylvester Comprehensive Cancer Center | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Marialby Donis Ramos 305-243-1000 mxd4514@med.miami.edu | |
| Principal Investigator: Jose Lutzky, MD | |
| Orlando Health | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Melinda Porter 321-841-7246 janice.porter@orlandohealth.com | |
| Principal Investigator: Sajeve Thomas, MD | |
| United States, Kentucky | |
| Norton Cancer Institute | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Ben Orem 502-629-2500 ext 19471 ben.orem@nortonhealthcare.org | |
| Principal Investigator: Jaspreet Grewal, MD | |
| United States, Michigan | |
| Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Marie Ventimiglia 313-576-9271 ventimim@karmanos.org | |
| Principal Investigator: Ira Winer, MD | |
| United States, Minnesota | |
| University of Minnesota, Masonic Cancer Center | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Manar Al-Assi malassi@umn.edu | |
| United States, New York | |
| Columbia University Herbert Irving Comprehensive Cancer Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Elizabeth Shelton, MPH cancerclinicaltrials@cumc.columbia.edu | |
| Principal Investigator: Brian Henick, MD | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: UNC Immunotherapy Team 919-445-4208 UNCImmunotherapy@med.unc.edu | |
| Principal Investigator: Jared Weiss, MD | |
| United States, Ohio | |
| The Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Cancer Answer Line 216-444-7923 | |
| Principal Investigator: James Isaacs, MD | |
| United States, Oregon | |
| Providence Cancer Institute Franz Clinic | Recruiting |
| Portland, Oregon, United States, 97213 | |
| Contact: Rom Leidner, MD 503-215-2614 CanRsrchStudies@providence.org | |
| Principal Investigator: Rom Leidner, MD | |
| United States, Pennsylvania | |
| Allegheny Hospitals Network | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Contact: Shelly Evans shelly.evans@ahn.org | |
| Principal Investigator: Yazan Samhouri, MD | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Barb Stadterman stadtermanbm@upmc.edu | |
| Principal Investigator: Jason Luke, MD | |
Sponsors and Collaborators
TScan Therapeutics, Inc.
Investigators
| Study Director: | Dawn Pinchasik, MD | TScan Therapeutics, Inc. |
| Responsible Party: | TScan Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT05812027 |
| Other Study ID Numbers: |
TSCAN-003 |
| First Posted: | April 13, 2023 Key Record Dates |
| Last Update Posted: | April 25, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by TScan Therapeutics, Inc.:
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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 |