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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • NT-112: Autologous, engineered T Cells targeting KRAS G12D
  • AZD0240: Autologous, engineered T Cells targeting KRAS G12D

Treatment groups

108 Participants
are divided into 2 treatment groups

Sponsors and collaborators