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NT-175

Phase 1

Non-small Cell Lung Cancer | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Sep 1, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

NT-175 · 1 trial · 8 indications

Phase 1 1
NCT05877599A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H MutationNon-small Cell Lung Cancer
RECRUITING45 Analytics
PHASE1RECRUITING
A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation
Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Module 1, Part 1: Safety of NT-175 in participants with unresectable, advanced, and/or metastatic solid tumours
28 days after infusion

Incidence of dose-limiting toxicities (DLTs) after the infusion of NT-175

Module 1, Part 2: Preliminary anti-tumour activity of NT-175 in participants with unresectable, advanced, and/or metastatic solid tumours
Up to 24 months after infusion

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)

Module 2: Safety of NT-175 in participants with haematological malignancies
Up to 28 days after infusion

\- Incidence of dose-limiting toxicities (DLTs) after the infusion of NT-175

Secondary Endpoints

Module 1, Part 1: Preliminary anti-tumor activity of NT-175 in participants with unresectable, advanced, and/or metastatic solid tumours
Up to 24 months after infusion
Module 2: Evaluate preliminary anti-tumour activity in participants with AML or MDS
Up to 24 months after infusion
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NT-175 for advanced malignanciesEXPERIMENTALTCR T cell therapy product

Interventions

NameTypeDescription
NT-175BIOLOGICAL* 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)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites23

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 ...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Recent Changes (Last 90 Days)

LOWSep 1, 2026NCT05877599lastUpdatePostDate: changed
LOWSep 1, 2026NCT05877599lastUpdatePostDate: changed
LOWAug 6, 2026NCT05877599lastUpdatePostDate: changed
LOWAug 6, 2026NCT05877599lastUpdatePostDate: changed
MEDIUMJul 13, 2026NCT05877599lastUpdatePostDate: changed
MEDIUMJul 13, 2026NCT05877599lastUpdatePostDate: changed
LOWJun 10, 2026NCT05877599lastUpdatePostDate: changed
LOWJun 10, 2026NCT05877599lastUpdatePostDate: changed

Frequently asked questions about NT-175

What is NT-175 used for?

NT-175 is an investigational monoclonal antibody being studied for the treatment of non-small cell lung cancer. It is also being evaluated in other advanced solid tumors and myeloid neoplasms, including head and neck squamous cell carcinoma, colorectal carcinoma, pancreatic adenocarcinoma, breast cancer, ovarian cancer, and AML/MDS.

What does NT-175 target?

NT-175 targets the TP53 R175H mutation in patients who are positive for the HLA-A*02:01 allele. This mutation is a specific alteration in the p53 tumor suppressor protein, and the drug is designed to recognize and bind to this mutated form.

Who is developing NT-175?

NT-175 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy.

What phase is NT-175 in?

NT-175 is currently in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and preliminary activity.

What clinical trials is NT-175 in?

NT-175 is being studied in a Phase 1 clinical trial with the identifier NCT05877599. This trial is recruiting 45 adult participants with advanced malignancies that are positive for HLA-A*02:01 and the TP53 R175H mutation. The study is being conducted in the United States.

Is NT-175 the same as any other drug?

NT-175 is a distinct investigational monoclonal antibody and is not known to be the same as any other approved or marketed drug. It is being developed specifically for cancers that carry the TP53 R175H mutation in HLA-A*02:01 positive patients.