Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
NT-112: Autologous, engineered T Cells targeting KRAS G12D: NT-112 targets KRAS G12D in the context of HLA-C\*08:02
AZD0240: Autologous, engineered T Cells targeting KRAS G12D: AZD0240 targets KRAS G12D in the context of HLA-A\*11:01 or HLA-A\*11:02
Study 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.
Eligibility
Primary outcome measure(s)
- Part A (Dose Escalation): Evaluate the safety of KRAS TCRTs in subjects with unresectable, advanced, and/or metastatic solid tumors — Through study completion, an average of 2 years
Incidence of DLTs, treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) - Part A (Dose Escalation): Evaluate MTD and recommended dose for expansion (RDE) — 28 days after infusion
Incidence of DLTs, treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) - Part B (Expansion): Further evaluate the safety of KRAS TCRTs at the RDE in subjects with unresectable, advanced, and/or metastatic solid tumors — 28 days after infusion
Incidence of DLTs, treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs)
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Duarte | California | Recruiting |
| Research Site | Los Angeles | California | Recruiting |
| Research Site | Newport Beach | California | Recruiting |
| Research Site | Jacksonville | Florida | Recruiting |
| Research Site | Chicago | Illinois | Recruiting |
| Research Site | Westwood | Kansas | Recruiting |
| Research Site | Boston | Massachusetts | Recruiting |
| Research Site | St Louis | Missouri | Recruiting |
| Research Site | New York | New York | Recruiting |
| Research Site | New York | New York | Recruiting |
| Research Site | Portland | Oregon | Recruiting |
| Research Site | Philadelphia | Pennsylvania | Recruiting |
| Research Site | Pittsburgh | Pennsylvania | Recruiting |
| Research Site | Nashville | Tennessee | Recruiting |
| Research Site | Dallas | Texas | Recruiting |
| Research Site | Galveston | Texas | Recruiting |
| Research Site | Houston | Texas | Recruiting |
| Research Site | Milwaukee | Wisconsin | Recruiting |
More AstraZeneca trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06218914 on ClinicalTrials.gov ↗ ← All trials in the USA