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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
NT-112 targets KRAS G12D in the context of HLA-C\*08:02
AZD0240 targets KRAS G12D in the context of HLA-A\*11:01 or HLA-A\*11:02
Research Site
Duarte, California, United States
RECRUITINGResearch Site
Los Angeles, California, United States
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
Part A (Dose Escalation): Evaluate the preliminary anti-tumor activity of KRAS TCRTs in subjects with unresectable, advanced, and/or metastatic solid tumors
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, determined by Investigator assessment * Best objective response (BOR) * Duration of response (DOR) * Clinical benefit rate (CBR) (complete response \[CR\], partial response \[PR\], stable disease \[SD\]) * Time to response (TTR) * Progression-free survival (PFS) * Overall survival (OS)
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
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, determined by Investigator assessment * Best objective response (BOR) * Duration of response (DOR) * Clinical benefit rate (CBR) (complete response \[CR\], partial response \[PR\], stable disease \[SD\]) * Time to response (TTR) * Progression-free survival (PFS) * Overall survival (OS)
AstraZeneca Clinical Study Information Center
CONTACT
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Research Site
Newport Beach, California, United States
RECRUITINGResearch Site
Jacksonville, Florida, United States
NOT_YET_RECRUITINGResearch Site
Chicago, Illinois, United States
RECRUITINGResearch Site
Westwood, Kansas, United States
RECRUITINGResearch Site
St Louis, Missouri, United States
RECRUITINGResearch Site
New York, New York, United States
RECRUITINGResearch Site
New York, New York, United States
NOT_YET_RECRUITINGResearch Site
Philadelphia, Pennsylvania, United States
RECRUITING...and 7 more locations
Time frame: Up to 24 months post infusion