Open-label, Phase 1, Multi-Center Master Protocol to Evaluate the Safety and Preliminary Anti-Tumor Activity of TCR-engineered T Cells Recognizing KRAS Mutations in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors
Summary
Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and/or Metastatic Solid Tumors.
Detailed description
This is a Phase 1, open-label, Phase 1, Multi-Center Master Protocol to evaluate the safety and preliminary Anti-Tumor activity of TCR-Engineered T cells (KRAS TCRTs) recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and/or Metastatic Solid Tumors.
Arms & interventions
- BiologicalNT-112: Autologous, engineered T Cells targeting KRAS G12D
NT-112 targets KRAS G12D in the context of HLA-C\*08:02
- BiologicalAZD0240: Autologous, engineered T Cells targeting KRAS G12D
AZD0240 targets KRAS G12D in the context of HLA-A\*11:01 or HLA-A\*11:02
Outcome measures
Primary
Part A (Dose Escalation): Evaluate the safety of KRAS TCRTs in subjects with unresectable, advanced, and/or metastatic solid tumors
Incidence of DLTs, treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: Through study completion, an average of 2 years
Part A (Dose Escalation): Evaluate MTD and recommended dose for expansion (RDE)
Incidence of DLTs, treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: 28 days after infusion
Part B (Expansion): Further evaluate the safety of KRAS TCRTs at the RDE in subjects with unresectable, advanced, and/or metastatic solid tumors
Incidence of DLTs, treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs)
Time frame: 28 days after infusion
Secondary
Part A (Dose Escalation): Evaluate the preliminary anti-tumor activity of KRAS TCRTs in subjects with unresectable, advanced, and/or metastatic solid tumors
Time frame: Up to 24 months post-infusion
Part B (Dose Expansion): Evaluate the preliminary anti-tumor activity of KRAS TCRTs at the RDE in subjects with unresectable, advanced, and/or metastatic solid tumors
Time frame: Up to 24 months post infusion
Eligibility criteria
Study locations (18)
Research Site
Duarte, California, 91010
Research Site
Los Angeles, California, 90095
Research Site
Newport Beach, California, 92663
Research Site
Jacksonville, Florida, 32224
Research Site
Chicago, Illinois, 60637
Research Site
Westwood, Kansas, 66205
Research Site
Boston, Massachusetts, 02115
Research Site
St Louis, Missouri, 63110
Research Site
New York, New York, 10016
Research Site
New York, New York, 10065
Research Site
Portland, Oregon, 97213
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Pittsburgh, Pennsylvania, 15237
Research Site
Nashville, Tennessee, 37203
Research Site
Dallas, Texas, 75246
Research Site
Galveston, Texas, 77555
Research Site
Houston, Texas, 77030
Research Site
Milwaukee, Wisconsin, 53226