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/or Metastatic Solid Tumors That Are Positive for the TP53 R175H Mutation
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), targeting TP53 R175H mutant solid tumors.
• Subjects must be at least 18 years of age, at the time of signing the informed consent.
• Subjects must be capable of giving signed informed consent.
• Subject must be diagnosed with one of the histologies below:
‣ NSCLC
⁃ Colorectal adenocarcinoma
⁃ HNSCC
⁃ Pancreatic adenocarcinoma
⁃ Breast cancer
⁃ Ovarian cancer
⁃ Any other solid tumor
• 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.
• Subject has advanced solid cancer, defined as unresectable, advanced, and/or 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.
• Subject has at least 1 measurable lesion per computed tomography (CT) scan or magnetic resonance imaging (MRI) per RECIST version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment
• Adequate hematological, renal, hepatic, pulmonary, and cardiac function
• Per Investigator judgement, subject is likely to complete study visits and/or procedures per the protocol and comply with study requirements for study participation