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
- Non-small Cell Lung Cancer
- Colorectal Carcinoma
- Pancreatic Ductal Adenocarcinoma
- Endometrial Cancer
- Solid Tumor, Adult
- KRAS G12D
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- AstraZeneca
- Enrolment target
- 108
- Started
- 22 March 2024
- Main results due
- 30 August 2027
- Study sites
- 18
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Key Inclusion Criteria: * Age ≥18 years * Diagnosed with NSCLC, Colorectal adenocarcinoma, Pancreatic adenocarcinoma, Endometrial Cancer or any other solid tumor * Tumors must harbor a KRAS G12D variant mutation and subject must be HLA-C\*08:02 positive, HLA-A\*11:01 or HLA-A\*11:02 positive in at least one allele * Subject has advanced solid cancer, defined as unresectable, advanced, and/or metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options. * Presence of at least 1 measurable lesion per RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment Key Exclusion Criteria: * Any other primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer * Known, active primary central nervous system (CNS) 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 the 12 months prior to enrollment. * History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment. * Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment. * Any form of primary immunodeficiency. * Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy) * Female of childbearing potential who is lactating or breast feeding at the time of enrollment * Prior treatment with pan-KRAS or KRAS G12D targeting agents unless presence of KRAS G12D mutation is confirmed after the completion of treatment with pan-KRAS or KRAS G12D targeting agents.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(18)
Research Site
Duarte, California, United States
Recruiting
Research Site
Los Angeles, California, United States
Recruiting
Research Site
Newport Beach, California, United States
Recruiting
Research Site
Jacksonville, Florida, United States
Recruiting
Research Site
Chicago, Illinois, United States
Recruiting
Research Site
Westwood, Kansas, United States
Recruiting
Research Site
Boston, Massachusetts, United States
Recruiting
Research Site
St Louis, Missouri, United States
Recruiting
Research Site
New York, New York, United States
Recruiting
Research Site
New York, New York, United States
Recruiting
Research Site
Portland, Oregon, United States
Recruiting
Research Site
Philadelphia, Pennsylvania, United States
Recruiting
Research Site
Pittsburgh, Pennsylvania, United States
Recruiting
Research Site
Nashville, Tennessee, United States
Recruiting
Research Site
Dallas, Texas, United States
Recruiting
Research Site
Galveston, Texas, United States
Recruiting
Research Site
Houston, Texas, United States
Recruiting
Research Site
Milwaukee, Wisconsin, United States
Recruiting
Showing 18 of 18 sites. 18 of the 18 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06218914. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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