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

Launched by ASTRAZENECA · Jan 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called NT-112 for adults with certain types of advanced cancer that have a specific genetic mutation known as KRAS G12D. The trial is focused on patients whose tumors are not removable by surgery and includes different types of cancer, such as non-small cell lung cancer, colorectal cancer, pancreatic cancer, and endometrial cancer. To be eligible for this trial, participants must be at least 18 years old, have been diagnosed with one of these cancers, and have the KRAS G12D mutation. Additionally, they need to have received at least one previous standard treatment that didn’t work and must be in good overall health.

Participants in this study will receive a unique therapy that uses their own immune cells, modified to target the cancer effectively. The trial is currently recruiting participants, and those who join can expect close monitoring and support throughout the treatment process. It’s important to note that certain health conditions may exclude someone from participating, such as recent serious illnesses or other active cancers. This trial offers a potential new option for patients who have limited treatment choices available to them.

Gender

ALL

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.