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Phase 1 Study for KRAS-Mutated Advanced Solid Tumors

This Phase 1 study is testing two new treatments, NT-112 and AZD0240, for people with advanced solid tumors that have a specific genetic change called a KRAS G12D mutation. These treatments are a type of cell therapy (TCR-Engineered T cells) that aim to target and fight cancer cells with this mutation. To join, your tumor must have the KRAS G12D mutation, and you must also have specific genetic markers called HLA-C*08:02, HLA-A*11:01, or HLA-A*11:02. The main goals of this study are to find out how safe these treatments are and to determine the best dose. Researchers will also look for early signs that the treatments are working against the cancer. This study is for adults aged 18 and older with non-small cell lung cancer, colorectal cancer, pancreatic cancer, endometrial cancer, or other solid tumors that are advanced or have spread.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll about 108 participants to evaluate the safety and initial effectiveness of the treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be evaluated through study completion, which is an average of 2 years. Specific safety evaluations will also occur 28 days after infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06218914

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
AstraZeneca
~108 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:NT-112: Autologous, engineered T Cells targeting KRAS G12DAZD0240: Autologous, engineered T Cells targeting KRAS G12D

At a glance

Recruiting sites
18 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A (Dose Escalation): Evaluate the safety of KRAS TCRTs in subjects with unresectable, advanced, and/or metastatic solid tumors
Measured over Through study completion, an average of 2 years
+2 more outcomes measured

Conditions

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

Explore related trials

Colorectal CarcinomaEndometrial CarcinomaLung Non-Small Cell CarcinomaPancreatic Ductal AdenocarcinomaSolid NeoplasmHLA-A GeneHLA-C Gene

Where it's being run

18 sites across 12 states
California3
Texas3
New York2
Pennsylvania2
Florida1
Illinois1
Kansas1
Massachusetts1

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Part A (Dose Escalation): Evaluate the safety of KRAS TCRTs in subjects with unresectable, advanced, and/or metastatic solid tumorsThrough 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 tumors28 days after infusion

    Incidence of DLTs, treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs)