Approval Probability
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NT-175 · 1 trial · 8 indications
Incidence of dose-limiting toxicities (DLTs) after the infusion of NT-175
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)
\- Incidence of dose-limiting toxicities (DLTs) after the infusion of NT-175
| Arm | Type | Description |
|---|---|---|
| NT-175 for advanced malignancies | EXPERIMENTAL | TCR T cell therapy product |
| Name | Type | Description |
|---|---|---|
| NT-175 | BIOLOGICAL | * Pre-conditioning by non-myeloablative chemotherapy with fludarabine and cyclophosphamide * Single infusion Autologous, engineered T Cells targeting TP53 R175H * Post-infusion recombinant interleukin-2 (rIL-2) |
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 ...
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NT-175 is an investigational monoclonal antibody being developed by AstraZeneca PLC for the treatment of advanced solid tumors, including non-small cell lung cancer. It is designed to target cancers that carry a specific biomarker profile: positivity for HLA-A*02:01 and the TP53 R175H mutation. NT-175 is currently in Phase 1 clinical development.
NT-175 is being studied for use in non-small cell lung cancer and other advanced malignancies that are positive for HLA-A*02:01 and the TP53 R175H mutation. It is an investigational therapy and has not been approved for any indication. Treatment is limited to adult participants enrolled in its ongoing clinical trial.
NT-175 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the ongoing Phase 1 study of NT-175 in patients with advanced malignancies, including non-small cell lung cancer, that are positive for HLA-A*02:01 and the TP53 R175H mutation.
NT-175 is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA or any other regulatory agency. The single ongoing Phase 1 trial is currently recruiting adult participants with advanced malignancies, including non-small cell lung cancer, who test positive for HLA-A*02:01 and the TP53 R175H mutation.
NT-175 is being evaluated in one Phase 1 trial, NCT05877599, titled A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation. The trial is recruiting in the United States with a planned enrollment of 45 participants and is an uncontrolled, non-randomized study.
The NCT05877599 trial enrolls adults aged 18 years and older of any sex who have advanced malignancies positive for HLA-A*02:01 and the TP53 R175H mutation. Eligible tumor types include non-small cell lung cancer, head and neck squamous cell carcinoma, colorectal carcinoma, pancreatic adenocarcinoma, breast cancer, ovarian cancer, other solid tumors, and myeloid neoplasms such as AML and MDS.