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

ConditionsNon-small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma Colorectal Carcinoma Pancreatic Adenocarcinoma Breast Cancer Other Solid Tumors Ovarian Cancer

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorAstraZeneca

About this trial

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.

Eligibility criteria

Qualifiers

Subjects must be at least 18 years of age, at the time of signing the informed consent.

Subjects must be capable of giving signed informed consent.

NSCLC

Colorectal adenocarcinoma

Disqualifiers

Any another primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer

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.

Trial design

Treatments tested in this trial

Autologous, engineered T Cells targeting TP53 R175H

Treatment groups

45 Participants

are divided into 3 treatment groups

Locations

Arizona

Research Site85234, Gilbert United States

California

Research Site91010, Duarte United States

Research Site92663, Newport Beach United States

Research Site90404, Santa Monica United States

Sponsors and collaborators

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov