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Trial NCT05877599

A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation

Phase
Phase 1
Sponsor
AstraZeneca
Conditions
Non-small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma; Colorectal Carcinoma; Pancreatic Adenocarcinoma; Breast Cancer; Other Solid Tumors; Ovarian Cancer; Myeloid Neoplasms (AML/MDS)
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Key Inclusion Criteria (Module 1) * Subjects must be at least 18 years of age * 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) * 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 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Adequate hematological, renal, hepatic, pulmonary, and cardiac function Key Exclusion Criteria (Module 1) * Any another primary malignancy within the 3 years prior to enrollmentPrior malignancy * Known, active primary central nervous system (CNS) malignancyBrain metastases * History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation. * History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.Cardiac * Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment. * Any form of primary immunodeficiency. * Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome. Key Inclusion Criteria (Module 2 - hematological malignancies) * At least 18 years of age * Diagnosis of AML or MDS that allows for efficacy assessments * Confirmation of TP53 R175H variant mutation in cancer cells * Subject must be HLA-A*02:01 positive (at least 1 allele) * ECOG performance status of 0 to 1 Key Exclusion Criteria (Module 2 - hematological malignancy) * Acute promyelocytic leukaemia or isolated extramedullary disease * Another primary malignancy within 2 years (with exceptions) * HSCT within 100 days or immunosuppression for GvHD within 4 weeks * History of CNS or other extramedullary leukaemic involvement unless a lumbar puncture is negative for leukemic cells * Prior stroke, ischemic attack, significant cardiac disease, heart failure * Prior adoptive modified cell therapy * Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.

Restrictions found (3)

Recruiting in Massachusetts

  • Research Site · Boston, Suffolk County
  • Research Site · Boston, Suffolk County