Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors
NCT ID: NCT06218914
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
24 participants
INTERVENTIONAL
2024-03-22
2044-04-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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NT-112
Part A Dose Escalation and Part B Dose Expansion of NT-112
NT-112: Autologous, engineered T Cells targeting KRAS G12D
NT-112 targets KRAS G12D in the context of HLA-C\*08:02
AZD0240
Part A Dose Escalation and Part B Dose Expansion of AZD0240
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Duarte, California, United States
Research Site
Los Angeles, California, United States
Research Site
Newport Beach, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Westwood, Kansas, United States
Research Site
St Louis, Missouri, United States
Research Site
New York, New York, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
Research Site
Dallas, Texas, United States
Research Site
Galveston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Aberdeen, Washington, United States
Research Site
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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NT-112-301
Identifier Type: -
Identifier Source: org_study_id