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
Purpose
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.
Conditions
- Non-small Cell Lung Cancer
- Colorectal Carcinoma
- Pancreatic Ductal Adenocarcinoma
- Endometrial Cancer
- Solid Tumor, Adult
- KRAS G12D
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 - 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
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NT-112 |
Dose Escalation of NT-112. |
|
Recruiting Locations
University of Kansas Cancer Center - Westwood Campus
Fairway, Kansas 66205
Fairway, Kansas 66205
More Details
- Status
- Recruiting
- Sponsor
- Neogene Therapeutics, Inc.
Detailed 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.