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
Primary:
Evaluate the safety of NT-175 in subjects with unresectable, advanced, and/or metastatic solid tumors
Evaluate MTD and RP2D(s)
Secondary:
Evaluate preliminary anti-tumor activity of NT-175 in subjects with unresectable, advanced, and/or metastatic solid tumors
Exploratory:
Evaluate PK and pharmacodynamics
Evaluate parameters associated with blood and/or tumor tissue and association with clinical outcomes
Evaluate the manufacturing feasibility of NT-175
- Rutgers Cancer Institute of New Jersey
Key Inclusion Criteria
- 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
- 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).
- 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
Key Exclusion Criteria
- 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
- Known, active primary central nervous system (CNS) malignancy
- History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or
solid organ transplantation.
- History of stroke or transient ischemic attack within the 12 months prior to
enrollment.
- History of clinically significant cardiac disease within the 6 months prior to
enrollment or heart failure at any time prior to enrollment.
- Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter,
prior to enrollment.
- History of severe immediate hypersensitivity reaction to cyclophosphamide,
fludarabine, or rIL-2; or known sensitivity or allergy to methotrexate, gentamicin,
or other aminoglycosides.
- Any form of primary immunodeficiency.
- Live vaccine ≤ 4 weeks prior to enrollment or plans to have a live vaccine prior to
planned lymphodepleting chemotherapy and/or NT-175 treatment.
- Active immune-mediated disease requiring systemic steroids or other
immunosuppressive treatment (except if related to prior checkpoint inhibitor
therapy)
- Female of childbearing potential who is lactating or breast feeding at the time of
enrollment.
- Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed
with Li-Fraumeni syndrome.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.