Trials / Recruiting
RecruitingNCT06218914
Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Non-small Cell Lung Cancer
- Colorectal Carcinoma
- Pancreatic Ductal Adenocarcinoma
- Endometrial Cancer
- Solid Tumor, Adult
- KRAS G12D
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | NT-112: Autologous, engineered T Cells targeting KRAS G12D | NT-112 targets KRAS G12D in the context of HLA-C\*08:02 |
| BIOLOGICAL | 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 |
Timeline
- Start date
- 2024-03-22
- Primary completion
- 2027-08-30
- Completion
- 2043-11-18
- First posted
- 2024-01-23
- Last updated
- 2026-03-09
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06218914. Inclusion in this directory is not an endorsement.