Actively Recruiting
Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors
Led by AstraZeneca · Updated on 2026-05-01
108
Participants Needed
18
Research Sites
1025 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with non-small cell lung cancer, colorectal adenocarcinoma, pancreatic adenocarcinoma, endometrial cancer, or another solid tumor
- Tumors must have KRAS G12D variant mutation and be positive for HLA-C08:02, HLA-A11:01, or HLA-A*11:02 in at least one allele
- Advanced solid cancer defined as unresectable, advanced, or metastatic disease (Stage III or IV) after at least one line of approved systemic standard of care treatment with no curative options
- At least one measurable lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at enrollment
You will not qualify if you...
- Any other primary malignancy within 3 years before enrollment except non-melanoma skin cancer, carcinoma in situ (e.g., cervix, bladder, breast), or low-grade prostate cancer
- Known active primary central nervous system malignancy
- History of prior adoptive cell and gene therapy, allogeneic stem cell transplant, or solid organ transplantation
- History of stroke or transient ischemic attack within 12 months before enrollment
- History of clinically significant cardiac disease within 6 months before enrollment or heart failure at any time before enrollment
- Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, before enrollment
- Any form of primary immunodeficiency
- Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except related to prior checkpoint inhibitor therapy)
- Female of childbearing potential who is lactating or breastfeeding at enrollment
- Prior treatment with pan-KRAS or KRAS G12D targeting agents unless KRAS G12D mutation is confirmed after completing that treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Research Site
Duarte, California, United States, 91010
Actively Recruiting
2
Research Site
Los Angeles, California, United States, 90095
Actively Recruiting
3
Research Site
Newport Beach, California, United States, 92663
Actively Recruiting
4
Research Site
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
Research Site
Chicago, Illinois, United States, 60637
Actively Recruiting
6
Research Site
Westwood, Kansas, United States, 66205
Actively Recruiting
7
Research Site
Boston, Massachusetts, United States, 02115
Actively Recruiting
8
Research Site
St Louis, Missouri, United States, 63110
Actively Recruiting
9
Research Site
New York, New York, United States, 10016
Actively Recruiting
10
Research Site
New York, New York, United States, 10065
Not Yet Recruiting
11
Research Site
Portland, Oregon, United States, 97213
Actively Recruiting
12
Research Site
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
13
Research Site
Pittsburgh, Pennsylvania, United States, 15237
Actively Recruiting
14
Research Site
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
Research Site
Dallas, Texas, United States, 75246
Actively Recruiting
16
Research Site
Galveston, Texas, United States, 77555
Actively Recruiting
17
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
18
Research Site
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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