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Recruiting Phase 1

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

NCT06218914 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2024-03-22
Last updated
2026-09-25

Condition(s) studied

Non-small Cell Lung CancerColorectal CarcinomaPancreatic Ductal AdenocarcinomaEndometrial CancerSolid Tumor, AdultKRAS G12D

Investigational drug(s) / intervention(s)

NT-112: Autologous, engineered T Cells targeting KRAS G12DAZD0240: Autologous, engineered T Cells targeting KRAS G12D

NT-112: Autologous, engineered T Cells targeting KRAS G12D: NT-112 targets KRAS G12D in the context of HLA-C\*08:02

AZD0240: Autologous, engineered T Cells targeting KRAS G12D: AZD0240 targets KRAS G12D in the context of HLA-A\*11:01 or HLA-A\*11:02

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Part A (Dose Escalation): Evaluate the safety of KRAS TCRTs in subjects with unresectable, advanced, and/or metastatic solid tumors — Through study completion, an average of 2 years
    Incidence of DLTs, treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
  • Part A (Dose Escalation): Evaluate MTD and recommended dose for expansion (RDE) — 28 days after infusion
    Incidence of DLTs, treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
  • Part B (Expansion): Further evaluate the safety of KRAS TCRTs at the RDE in subjects with unresectable, advanced, and/or metastatic solid tumors — 28 days after infusion
    Incidence of DLTs, treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs)

Trial sites (18)

FacilityCityRegionStatus
Research Site Duarte California Recruiting
Research Site Los Angeles California Recruiting
Research Site Newport Beach California Recruiting
Research Site Jacksonville Florida Recruiting
Research Site Chicago Illinois Recruiting
Research Site Westwood Kansas Recruiting
Research Site Boston Massachusetts Recruiting
Research Site St Louis Missouri Recruiting
Research Site New York New York Recruiting
Research Site New York New York Recruiting
Research Site Portland Oregon Recruiting
Research Site Philadelphia Pennsylvania Recruiting
Research Site Pittsburgh Pennsylvania Recruiting
Research Site Nashville Tennessee Recruiting
Research Site Dallas Texas Recruiting
Research Site Galveston Texas Recruiting
Research Site Houston Texas Recruiting
Research Site Milwaukee Wisconsin Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06218914 on ClinicalTrials.gov ↗ ← All trials in the USA