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Rock","78665",{"type":47,"coordinates":186},[187,188],-97.6789,30.50826,{"lat":188,"lon":187},{"facility":40,"status":41,"city":191,"state":192,"zip":193,"country":45,"cosmosGeoPoint":194,"geoPoint":198,"contacts":28},"Milwaukee","Wisconsin","53226",{"type":47,"coordinates":195},[196,197],-87.90647,43.0389,{"lat":197,"lon":196},{"type":200,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100506685",false,"NCT05877599","A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and\u002For Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation","An Open-label, Phase 1, Multicenter Study to Evaluate the Safety and Preliminary Anti-tumor Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Subjects With Unresectable, Advanced and\u002For Metastatic Solid Tumors That Are Positive for the TP53 R175H Mutation","Key Inclusion Criteria\n\n* Subjects must be at least 18 years of age, at the time of signing the informed consent.\n* Subjects must be capable of giving signed informed consent.\n* Subject must be diagnosed with one of the histologies below:\n\n  * NSCLC\n  * Colorectal adenocarcinoma\n  * HNSCC\n  * Pancreatic adenocarcinoma\n  * Breast cancer\n  * Ovarian cancer\n  * Any other solid tumor\n* Tumors must harbor a TP53 R175H variant mutation and subject must be HLA-A\\*02:01 positive (at least 1 allele) as confirmed by an CLIA-accredited laboratory-based test.\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Subject has at least 1 measurable lesion per computed tomography (CT) scan or magnetic resonance imaging (MRI) per RECIST version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment\n* Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n* Per Investigator judgement, subject is likely to complete study visits and\u002For procedures per the protocol and comply with study requirements for study participation\n\nKey Exclusion Criteria\n\n* Any another primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of stroke or transient ischemic attack within the 12 months prior to enrollment.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or rIL-2; or known sensitivity or allergy to methotrexate, gentamicin, or other aminoglycosides.\n* Any form of primary immunodeficiency.\n* Live vaccine ≤ 4 weeks prior to enrollment or plans to have a live vaccine prior to planned lymphodepleting chemotherapy and\u002For NT-175 treatment.\n* Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy)\n* Female of childbearing potential who is lactating or breast feeding at the time of enrollment.\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.","ALL","18 Years",{"count":210,"type":211},45,"ESTIMATED","INTERVENTIONAL",[214],"PHASE1","Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\\*02:01-restricted T cell receptor (TCR), 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