Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-05-13
45
Participants Needed
18
Research Sites
315 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 solid tumors.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at the time of informed consent
- Able to provide signed informed consent
- Diagnosed with one of the following: NSCLC, colorectal adenocarcinoma, HNSCC, pancreatic adenocarcinoma, breast cancer, ovarian cancer, or any other solid tumor
- Tumors must have TP53 R175H mutation and participant must be HLA-A*02:01 positive confirmed by a CLIA-accredited test
- Have advanced, unresectable, or metastatic cancer (Stage III or IV) after at least one standard treatment, with no curative options
- At least one measurable tumor lesion per CT or MRI scan by RECIST 1.1
- ECOG performance status of 0 to 1 at enrollment
- Adequate blood, kidney, liver, lung, and heart function
- Likely able to complete study visits and follow protocol requirements as judged by the investigator
You will not qualify if you...
- Another primary cancer within 3 years before enrollment (except non-melanoma skin cancer, carcinoma in situ, or low-grade prostate cancer)
- Active primary central nervous system cancer
- Previous adoptive cell or gene therapy, allogeneic stem cell transplant, or solid organ transplant
- Stroke or transient ischemic attack within 12 months before enrollment
- Significant heart disease within 6 months before enrollment or any prior heart failure
- Systemic therapy within at least 2 weeks or 3 half-lives before enrollment
- Severe allergic reaction to cyclophosphamide, fludarabine, or rIL-2; or allergy to methotrexate, gentamicin, or aminoglycosides
- Any primary immunodeficiency
- Live vaccine within 4 weeks before enrollment or planned before chemotherapy or NT-175 treatment
- Active immune disease needing systemic steroids or immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy)
- Female who is breastfeeding or lactating at enrollment
- Known Li-Fraumeni syndrome or family history of Li-Fraumeni syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Research Site
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
Research Site
Duarte, California, United States, 91010
Actively Recruiting
3
Research Site
Newport Beach, California, United States, 92663
Actively Recruiting
4
Research Site
Santa Monica, California, United States, 90404
Actively Recruiting
5
Research Site
Jacksonville, Florida, United States, 32224
Actively Recruiting
6
Research Site
Miami, Florida, United States, 33136
Withdrawn
7
Research Site
Tampa, Florida, United States, 33612
Withdrawn
8
Research Site
Boston, Massachusetts, United States, 02115
Actively Recruiting
9
Research Site
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
10
Research Site
New York, New York, United States, 10065
Actively Recruiting
11
Research Site
Charlotte, North Carolina, United States, 28204
Withdrawn
12
Research Site
Winston-Salem, North Carolina, United States, 27103
Withdrawn
13
Research Site
Portland, Oregon, United States, 97213
Actively Recruiting
14
Research Site
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
15
Research Site
Nashville, Tennessee, United States, 37203
Actively Recruiting
16
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
17
Research Site
Round Rock, Texas, United States, 78665
Actively Recruiting
18
Research Site
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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