A Study of NT-112 in HLA-C*08:02-Positive Adult Subjects With Unresectable, Advanced, and/ or Metastatic Solid Tumors Positive for the KRAS G12D Mutation

Last updated: April 25, 2025
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

1

Condition

Pancreatic Cancer

Endometriosis

Cancer/tumors

Treatment

NT-112: Autologous, engineered T Cells targeting KRAS G12D

Clinical Study ID

NCT06218914
NT-112-301
  • All Genders

Study Summary

Phase I Study of NT-112, an autologous T-cell therapy product genetically engineered to express an HLA-C*08:02-restricted T cell receptor (TCR), targeting KRAS G12D mutant solid tumors.

Eligibility Criteria

Inclusion

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*08:02positive

  • Subject has advanced solid cancer, defined as unresectable, advanced, and/ormetastatic disease (Stage III or IV) after at least 1 line of approved systemicstandard of care (SOC) treatment regimen and for which there are no availablecurative 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 timeof enrollment

Exclusion

Key Exclusion Criteria:

  • Any other primary malignancy within the 3 years prior to enrollment (except fornon-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) orlow-grade prostate cancer

  • Known, active primary central nervous system (CNS) malignancy

  • History of prior adoptive cell and gene therapy, allogeneic stem cell transplant orsolid organ transplantation.

  • History of stroke or transient ischemic attack within the 12 months prior toenrollment.

  • History of clinically significant cardiac disease within the 6 months prior toenrollment 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 otherimmunosuppressive treatment (except if related to prior checkpoint inhibitortherapy)

  • Female of childbearing potential who is lactating or breast feeding at the time ofenrollment

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: NT-112: Autologous, engineered T Cells targeting KRAS G12D
Phase: 1
Study Start date:
April 04, 2024
Estimated Completion Date:
August 29, 2042

Study Description

This is a Phase 1, open-label, multicenter study to evaluate the safety and preliminary antitumor activity of NT-112 in HLA-C*08:02 subjects with unresectable, advanced, and/or metastatic NSCLC, colorectal adenocarcinoma, pancreatic adenocarcinoma, endometrial cancer, or any other solid tumor histology that is positive for the KRAS G21D mutation.

Connect with a study center

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • Research Site

    Duarte, California 91010
    United States

    Site Not Available

  • Research Site

    Los Angeles, California 90095
    United States

    Site Not Available

  • UCLA Health Jonsson Comprehensive Cancer Center

    Los Angeles, California 90024
    United States

    Active - Recruiting

  • Hoag Hospital Newport Beach

    Newport Beach, California 92658
    United States

    Active - Recruiting

  • Research Site

    Newport Beach, California 92663
    United States

    Site Not Available

  • University of Kansas Cancer Center - Westwood Campus

    Fairway, Kansas 66205
    United States

    Site Not Available

  • Research Site

    Westwood, Kansas 66205
    United States

    Site Not Available

  • Research Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine in St. Louis

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Washington University School of Medicine in St. Louis

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Research Site

    New York, New York 10016
    United States

    Site Not Available

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Site Not Available

  • Research Site

    Pittsburgh, Pennsylvania 15237
    United States

    Site Not Available

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • Research Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Baylor Scott & White Health / Texas Oncology, PA

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • Research Site

    Dallas, Texas 75246
    United States

    Site Not Available

  • Research Site

    Galveston, Texas 77555
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    Aberdeen, Washington 98520
    United States

    Site Not Available

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

  • Research Site

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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