RECRUITING

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

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Conditions

Non-small Cell Lung CancerHead and Neck Squamous Cell CarcinomaColorectal CarcinomaPancreatic AdenocarcinomaBreast CancerOther Solid TumorsOvarian CancerCell therapyTP53Solid tumorsTCR

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2023-07-27
Study Completion:2039-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05877599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
877-240-9479
information.center@astrazeneca.com

Principal Investigator

AstraZeneca
STUDY_DIRECTOR
AstraZeneca

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
University of California, Los Angeles (UCLA)
Los Angeles, California, 90095
United States
Hoag Medical Group
Newport Beach, California, 92663
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Rutgers University
New Brunswick, New Jersey, 09803
United States
Providence Cancer Institute
Portland, Oregon, 97225
United States
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, 37203
United States
Baylor Scott & White Medical Center
Dallas, Texas, 75246
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Neogene Therapeutics, Inc.

  • AstraZeneca, STUDY_DIRECTOR, AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-27
Study Completion Date2039-08

Study Record Updates

Study Start Date2023-07-27
Study Completion Date2039-08

Terms related to this study

Keywords Provided by Researchers

  • Cell therapy
  • TP53
  • Solid tumors
  • Non-small cell lung cancer
  • Head and neck squamous cell carcinoma
  • Colorectal carcinoma
  • Pancreatic adenocarcinoma
  • Breast Cancer
  • Ovarian Cancer
  • TCR

Additional Relevant MeSH Terms

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