Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06218914 | RECRUITING | Non-small Cell Lung Cancer

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

AstraZeneca

Brief Summary:

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.

Condition or disease

Non-small Cell Lung Cancer

Colorectal Carcinoma

Pancreatic Ductal Adenocarcinoma

Endometrial Cancer

Solid Tumor, Adult

KRAS G12D

Intervention/treatment

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

AZD0240: Autologous, engineered T Cells targeting KRAS G12D

Phase

PHASE1

Detailed Description:

This is a Phase 1, open-label, Phase 1, Multi-Center Master Protocol to evaluate the safety and preliminary Anti-Tumor activity of TCR-Engineered T cells (KRAS TCRTs) recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and/or Metastatic Solid Tumors.

Study Type : INTERVENTIONAL
Estimated Enrollment : 24 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2024-04-04
Estimated Primary Completion Date : 2027-08-30
Estimated Study Completion Date : 2044-04-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors

Location Details

NCT06218914

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Research Site

Duarte, California, United States, 91010

RECRUITING

United States, California

Research Site

Los Angeles, California, United States, 90095

RECRUITING

United States, California

Research Site

Newport Beach, California, United States, 92663

RECRUITING

United States, Kansas

Research Site

Westwood, Kansas, United States, 66205

RECRUITING

United States, Missouri

Research Site

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, New York

Research Site

New York, New York, United States, 10016

NOT YET RECRUITING

United States, Pennsylvania

Research Site

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, Pennsylvania

Research Site

Pittsburgh, Pennsylvania, United States, 15237

RECRUITING

United States, Tennessee

Research Site

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

Research Site

Dallas, Texas, United States, 75246

RECRUITING

United States, Texas

Research Site

Galveston, Texas, United States, 77555

RECRUITING

United States, Texas

Research Site

Houston, Texas, United States, 77030

RECRUITING

United States, Washington

Research Site

Aberdeen, Washington, United States, 98520

RECRUITING

United States, Wisconsin

Research Site

Milwaukee, Wisconsin, United States, 53226