A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation
NCT ID: NCT05877599
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
46 participants
INTERVENTIONAL
2023-07-12
2029-07-31
Brief Summary
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Detailed Description
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Dose Escalation will investigate escalating doses of NT-175 in adult subjects with eligible solid tumor histologies and will evaluate the safety and MTD.
Disease Histology Evaluation will further evaluate the safety and preliminary anti-tumor activity at or below the MTD in disease specific histologies and determine the RP2D. .
Disease Cohort Expansion will further evaluate the preliminary anti-tumor activity and safety of NT-175 at the RP2D in disease specific settings.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Escalation and Expansion
Dose Escalation of TCR T cell product
Autologous, engineered T Cells targeting TP53 R175H
* Pre-conditioning by non-myeloablative chemotherapy with fludarabine and cyclophosphamide
* Single infusion TCR T cells
* Post-infusion recombinant interleukin-2 (rIL-2)
Part 1: Disease Histology Evaluation
TCR T Cell Product at the MTD
Autologous, engineered T Cells targeting TP53 R175H
* Pre-conditioning by non-myeloablative chemotherapy with fludarabine and cyclophosphamide
* Single infusion TCR T cells
* Post-infusion recombinant interleukin-2 (rIL-2)
Part 2: Disease Cohort Expansion
TCR T Cell Product at the RP2D
Autologous, engineered T Cells targeting TP53 R175H
* Pre-conditioning by non-myeloablative chemotherapy with fludarabine and cyclophosphamide
* Single infusion TCR T cells
* Post-infusion recombinant interleukin-2 (rIL-2)
Interventions
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Autologous, engineered T Cells targeting TP53 R175H
* Pre-conditioning by non-myeloablative chemotherapy with fludarabine and cyclophosphamide
* Single infusion TCR T cells
* Post-infusion recombinant interleukin-2 (rIL-2)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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) 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) per RECIST version 1.1.
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Gilbert, Arizona, United States
Research Site
Duarte, California, United States
Research Site
Newport Beach, California, United States
Research Site
Santa Monica, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Boston, Massachusetts, United States
Research Site
New Brunswick, New Jersey, United States
Research Site
New York, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Portland, Oregon, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
Research Site
Houston, Texas, United States
Research Site
Round Rock, Texas, United States
Research Site
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Other Identifiers
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NT-175-201
Identifier Type: -
Identifier Source: org_study_id
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