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
- Conditions
- Head and Neck Squamous Cell CarcinomaColorectal CarcinomaBreast CancerPancreatic AdenocarcinomaOther Solid TumorsNon-small Cell Lung CancerOvarian Cancer
- Interventions
- Registration Number
- NCT05877599
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
This is a Phase 1, open-label, multicenter study to evaluate the safety and preliminary antitumor activity of NT-175 in HLA-A\*02:01 subjects with unresectable, advanced, and/or metastatic NSCLC, colorectal adenocarcinoma, HNSCC, pancreatic adenocarcinoma, ovarian cancer, breast cancer, or any other solid tumor histologies that are positive for the TP53 R175H mutation.
Dose Escalation will investigate escalating doses of NT-175 in adult subjects with eligible solid tumor histologies and will evaluate the safety and MTD.
Disease Histology Evaluation will further evaluate the safety and preliminary anti-tumor activity at or below the MTD in disease specific histologies and determine the RP2D. .
Disease Cohort Expansion will further evaluate the preliminary anti-tumor activity and safety of NT-175 at the RP2D in disease specific settings.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 162
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 1: Disease Histology Evaluation Autologous, engineered T Cells targeting TP53 R175H TCR T Cell Product at the MTD Dose Escalation and Expansion Autologous, engineered T Cells targeting TP53 R175H Dose Escalation of TCR T cell product Part 2: Disease Cohort Expansion Autologous, engineered T Cells targeting TP53 R175H TCR T Cell Product at the RP2D
- Primary Outcome Measures
Name Time Method Part 1: Safety of NT-175 in subjects with unresectable, advanced, and/or metastatic solid tumors Up to 24 months post-infusion Incidence of adverse events and serious adverse events
Part 2: Preliminary anti-tumor activity of NT-175 in subjects with unresectable, advanced, and/or metastatic solid tumors Up to 24 months after infusion Progression-free survival (PFS) per RECIST V1.1 determined by Investigator assessment.
Part 2: Further Evaluate the safety of NT-175 at the RP2D in subjects with unresectable, advanced, and/or metastatic solid tumors Up to 24 months after infusion Treatment-emergent adverse events, and serios adverse events
- Secondary Outcome Measures
Name Time Method Part 1: Preliminary anti-tumor activity of NT-175 in subjects with unresectable, advanced, and/or metastatic solid tumors Up to 24 months after infusion Progression-free survival (PFS) per RECIST V1.1 determined by Investigator assessment.
Trial Locations
- Locations (9)
City of Hope
🇺🇸Duarte, California, United States
University of California, Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
Hoag Medical Group
🇺🇸Newport Beach, California, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Rutgers University
🇺🇸New Brunswick, New Jersey, United States
Providence Cancer Institute
🇺🇸Portland, Oregon, United States
Sarah Cannon Research Institute (SCRI) Oncology Partners
🇺🇸Nashville, Tennessee, United States
Baylor Scott & White Medical Center
🇺🇸Dallas, Texas, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States