Assessing Frequency of HLA-Genotypes and Tumor Antigen Expression in Subjects with Relapsed/Refractory, Advanced-Stage Solid Tumors that may Qualify for T Cell Receptor Based Therapies.
Study Identifier:
TK-SCR-01
CT.gov Identifier:
N/A
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
Recruiting
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Study Summary
To assess the frequency of human leukocyte antigen (HLA)-A*02:01genotype and tumoral expression of melanoma-associated antigen 1 (MAGE-A1) in subjects with relapsed/refractory, advanced-stage solid tumors
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Bladder
Breast Cancers
Non-Small Cell Lung Cancer
Ovarian
Melanoma
Gastric
Head & Neck
Solid Tumor
Soft Tissue Sarcoma
Mesothelioma
Digestive & Intestinal
Neuroendocrine
Anal
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
IV
Sex
Female & Male
Age
18+ years
Study Drug
Drug: A blood sample will be collected for HLA-A*02: 01 genotyping （if not already known from medical history） during a scheduled, routine blood draw and to have a stored and accessible tumor sample available that can be stained for MAGE-A1 expression by immunohistochemistry (IHC).
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
Inclusion criteria
- 1. Signed written informed consent.
- 2. Histologically or cytologically confirmed diagnosis of relapsed/refractory,
- advanced stage solid tumor that may express MAGE-A1.
- 3. Subject received at least one line of approved systemic therapy and is
- declared to be in a non-curable disease state as per treating physician*s
- current assessment.
- 4. Availability of a stored, accessible tumor sample for IHC.
- 5. Ability to provide a blood sample.
- 6. Age >= 18 years.
- 7. Life expectancy > 6 months as per treating physician*s assessment.
Exclusion criteria
- 1. Any bleeding or coagulation disorder or other condition that would present
- the subject with an undue risk when undergoing a venous blood draw.
- 2. Any other condition that could interfere with subject's safety, obtaining
- informed consent, or compliance to the screening study procedures.
- 3. Presence of any organ toxicities or other conditions that would preclude
- intense future anticancer treatments such as required for T cell receptor
- therapy.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Barcelona
Barcelona, Spain, 08023
Investigator
Tatiana Hernandez Guerrero
Status
Recruitment on Hold
Condition(s) Treated at Site
Bladder
Breast Cancers
Non-Small Cell Lung Cancer
Ovarian
Melanoma
Gastric
Head & Neck
Solid Tumor
Soft Tissue Sarcoma
Mesothelioma
Digestive & Intestinal
Neuroendocrine
Anal