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NCT05877599From ClinicalTrials.govRecruiting

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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