A Phase 1 Study of NT-175 in People With Advanced Solid Tumors

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Full Title

An Open-label, Phase 1, Multicenter Study to Evaluate the Safety and Preliminary Anti-tumor activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Subjects with Unresectable, Advanced and/or Metastatic Solid Tumors That Are Positive for the TP53 R175H Mutation

Purpose

Researchers want to find the best dose of NT-175 in people with advanced solid tumors. The people in this study have cancers that are inoperable (cannot be surgically removed) or metastatic (have spread). The types of tumors include:

  • Non-small cell lung cancer
  • Colorectal cancer
  • Head and neck squamous cell carcinoma
  • Pancreatic cancer
  • Ovarian cancer
  • Breast cancer

In addition, the cancers have a mutation (change) in the TP53 R175H gene. The study participants also have a molecule called HLA-A*02:01 on their cells.

NT-175 is made in a laboratory using your collected white blood cells (T cells). The T cells in NT-175 have been genetically changed so they target cells with mutated TP53 R175H. NT-175 is given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have an inoperable or metastatic solid tumor with a mutated TP53 R175H gene.
  • Be positive for HLA-A*02:01.
  • Have cancer that keeps growing after treatment.
  • Have completed prior anti-cancer therapy at least 2 weeks before getting NT-175.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Adam Schoenfeld’s office at 646-608-2091.

Protocol

25-078

Phase

Phase I (phase 1)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05877599