RECRUITING

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

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Conditions

Non-small Cell Lung CancerColorectal CarcinomaPancreatic Ductal AdenocarcinomaEndometrial CancerSolid Tumor, AdultKRAS G12DTCR-T cell therapyKRASAutologousPDACNSCLCColorectal CancerSolid tumorsHLA-C*08:02HLA-A*11:01HLA-A*11:02

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-04-04
Study Completion:2044-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06218914

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years
  2. * Diagnosed with NSCLC, Colorectal adenocarcinoma, Pancreatic adenocarcinoma, Endometrial Cancer or any other solid tumor
  3. * 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
  4. * 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.
  5. * Presence of at least 1 measurable lesion per RECIST v1.1
  6. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment
  1. * 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
  2. * Known, active primary central nervous system (CNS) malignancy
  3. * History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.
  4. * History of stroke or transient ischemic attack within the 12 months prior to enrollment.
  5. * History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.
  6. * Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.
  7. * Any form of primary immunodeficiency.
  8. * Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy)
  9. * Female of childbearing potential who is lactating or breast feeding at the time of enrollment
  10. * 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.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Duarte, California, 91010
United States
Research Site
Los Angeles, California, 90095
United States
Research Site
Newport Beach, California, 92663
United States
Research Site
Westwood, Kansas, 66205
United States
Research Site
Saint Louis, Missouri, 63110
United States
Research Site
New York, New York, 10016
United States
Research Site
Philadelphia, Pennsylvania, 19107
United States
Research Site
Pittsburgh, Pennsylvania, 15237
United States
Research Site
Nashville, Tennessee, 37203
United States
Research Site
Dallas, Texas, 75246
United States
Research Site
Galveston, Texas, 77555
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Aberdeen, Washington, 98520
United States
Research Site
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-04
Study Completion Date2044-04-15

Study Record Updates

Study Start Date2024-04-04
Study Completion Date2044-04-15

Terms related to this study

Keywords Provided by Researchers

  • TCR-T cell therapy
  • KRAS
  • KRAS G12D
  • Autologous
  • PDAC
  • NSCLC
  • Colorectal Cancer
  • Solid tumors
  • Pancreatic Ductal Adenocarcinoma
  • HLA-C*08:02
  • HLA-A*11:01
  • HLA-A*11:02

Additional Relevant MeSH Terms

  • Non-small Cell Lung Cancer
  • Colorectal Carcinoma
  • Pancreatic Ductal Adenocarcinoma
  • Endometrial Cancer
  • Solid Tumor, Adult
  • KRAS G12D