A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation
An Open-label, Phase 1, Multicentre Platform Study to Evaluate the Safety and Preliminary Anti-tumour Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Participants With Advanced Malignancies That Are Positive for the TP53 R175H Mutation
- 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)
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- AstraZeneca
- Enrolment target
- 45
- Started
- 12 July 2023
- Main results due
- 31 July 2029
- Study sites
- 20
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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 enrollment * 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 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. * 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.
What this study is about
In the sponsor’s own words, from the registry.
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 malignancies
Study sites(20)
Research Site
Gilbert, Arizona, United States
Recruiting
Research Site
Duarte, California, United States
Recruiting
Research Site
Los Angeles, California, United States
Recruiting
Research Site
Newport Beach, California, United States
Recruiting
Research Site
Santa Monica, California, United States
Recruiting
Research Site
Jacksonville, Florida, United States
Recruiting
Research Site
Miami, Florida, United States
Withdrawn
Research Site
Tampa, Florida, United States
Withdrawn
Research Site
Boston, Massachusetts, United States
Recruiting
Research Site
Boston, Massachusetts, United States
Recruiting
Research Site
New Brunswick, New Jersey, United States
Recruiting
Research Site
New York, New York, United States
Recruiting
Research Site
Charlotte, North Carolina, United States
Withdrawn
Research Site
Winston-Salem, North Carolina, United States
Withdrawn
Research Site
Portland, Oregon, United States
Recruiting
Research Site
Pittsburgh, Pennsylvania, United States
Recruiting
Research Site
Nashville, Tennessee, United States
Recruiting
Research Site
Houston, Texas, United States
Recruiting
Research Site
Round Rock, Texas, United States
Recruiting
Research Site
Milwaukee, Wisconsin, United States
Recruiting
Showing 20 of 20 sites. 16 of the 20 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05877599. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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