No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
45 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for adults with certain advanced cancers that have a specific genetic mutation. Participants will receive a type of treatment called NT-175, which uses modified T cells to help fight cancer.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with advanced non-small cell lung cancer, colorectal cancer, head and neck cancer, pancreatic cancer, breast cancer, ovarian cancer, or another solid tumor.
My tumor has the TP53 R175H mutation and I am HLA-A*02:01 positive.
I have advanced cancer that cannot be removed by surgery and for which there are no curative treatment options.
I have at least one measurable tumor.
My performance status is between 0 and 1.
I have adequate health in my blood, kidneys, liver, lungs, and heart.
You may not be able to join if
I have had another primary cancer within the last 3 years.
I have a known active central nervous system cancer.
I have had previous gene or cell therapy, a stem cell transplant, or an organ transplant.
I have had significant heart problems in the last 6 months or have heart failure.
I have received systemic therapy within the last 2 weeks.
I have any form of primary immunodeficiency.
I or a close relative have Li-Fraumeni syndrome.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 …
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.