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NCT06218914From ClinicalTrials.govRecruiting

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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Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors | Trialion