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A Study of NT-175 for Advanced Cancers with TP53 R175H Mutation

This study is testing a new treatment called NT-175 for adults with advanced cancers, including non-small cell lung cancer, colorectal cancer, head and neck cancer, pancreatic cancer, and breast cancer. NT-175 is a type of cell therapy where your own immune cells (T cells) are specially engineered to find and fight cancer cells that have a specific change in their DNA called the TP53 R175H mutation. To join, your cancer must have this mutation, and you must also have a specific genetic marker called HLA-A*02:01. The study will look at how safe NT-175 is and if it can shrink tumors. Researchers will check for safety for up to 24 months and tumor activity for up to 24 months after treatment.

Study design
This is a Phase 1, open-label study enrolling about 45 participants. It will test increasing doses of NT-175 to find the safest and most effective dose.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for up to 24 months after receiving NT-175, and for tumor activity for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
AstraZeneca
~45 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:NT-175

At a glance

Recruiting sites
14 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Module 1, Part 1: Safety of NT-175 in participants with unresectable, advanced, and/or metastatic solid tumours
Measured over 28 days after infusion
+4 more outcomes measured

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)

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Acute Myeloid LeukemiaBreast CarcinomaColorectal CarcinomaHead and Neck Squamous Cell CarcinomaHematologic NeoplasmLung Non-Small Cell CarcinomaMalignant Ovarian NeoplasmMyelodysplastic SyndromePancreatic CarcinomaSolid NeoplasmHLA-A GeneTP53 Gene

Where it's being run

18 sites across 12 states
California3
Florida3
North Carolina2
Texas2
Arizona1
Massachusetts1
New Jersey1
New York1

Study leadership

  • AstraZeneca · STUDY_DIRECTOR · AstraZeneca

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

Exclusion

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.
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 trial measures

  • Module 1, Part 1: Safety of NT-175 in participants with unresectable, advanced, and/or metastatic solid tumours28 days after infusion

    Incidence of dose-limiting toxicities (DLTs) after the infusion of NT-175

  • Module 1, Part 1: Safety of NT-175 in participants with unresectable, advanced, and/or metastatic solid tumoursUp to 24 months post-infusion

    Incidence of Treatment Emergent Adverse Events (TEAE) Serious Adverse Events (SAE)

  • Module 1, Part 2: Preliminary anti-tumour activity of NT-175 in participants with unresectable, advanced, and/or metastatic solid tumoursUp to 24 months after infusion

    Per RECIST v1.1 determined by Investigator assessment: * Objective Response Rate (ORR) * Best Overall Response (BOR) * Duration of Response (DOR) * Clinical Benefit Rate (CBR) * Time to Response (TTR) * Progression-free survival (PFS) * Overall Survival (OS)

  • Module 2: Safety of NT-175 in participants with haematological malignanciesUp to 28 days after infusion

    \- Incidence of dose-limiting toxicities (DLTs) after the infusion of NT-175

  • Module 2: Safety of NT-175 in participants with haematological malignanciesUp to 24 months after infusion

    * Incidence of Treatment Emergent Adverse Events (TEAE) * Serious Adverse Events (SAE)