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RecruitingPhase 1

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

Open-label, Phase 1, Multi-Center Master Protocol to Evaluate the Safety and Preliminary Anti-Tumor Activity of TCR-engineered T Cells Recognizing KRAS Mutations in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests T cells, a type of immune cell, changed in a lab to target cancer with a KRAS gene change. It is for adults with solid tumors that cannot be removed by surgery, are advanced, or have spread, after at least one standard treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You have a solid tumor, such as non-small cell lung, colon, rectal, pancreatic, or uterine lining cancer.
  • Your tumor has the KRAS G12D gene change. You also have at least one copy of HLA-C*08:02, HLA-A*11:01, or HLA-A*11:02, which are immune system gene types.
  • Your cancer is stage III or IV and cannot be removed by surgery, is advanced, or has spread. You have had at least one approved standard treatment that works throughout the body, and no treatment that could cure your cancer is available.
  • You have at least one tumor that can be measured using the study’s rules.
  • You can do all usual activities, or you have limits only with hard physical activity (ECOG score 0 or 1).

Who can't join

  • You had another separate cancer in the past 3 years. Exceptions include non-melanoma skin cancer, cancer that has stayed where it first formed, and low-grade prostate cancer.
  • You have a known, active cancer that started in the brain or spinal cord.
  • You have had cell and gene therapy, a stem cell transplant from a donor, or an organ transplant.
  • You had a stroke or mini-stroke in the past 12 months, serious heart disease in the past 6 months, or heart failure at any time.
  • You recently had treatment that works throughout the body. The waiting period is 2 weeks or 3 drug half-lives, whichever is shorter. A half-life is the time it takes for half the drug to leave your body.
  • You have a condition you were born with that weakens your immune system. Or you have an active immune-related disease needing steroids or other drugs that lower immune activity throughout the body, unless it is related to past checkpoint inhibitor treatment, a type of immune therapy.
  • You can become pregnant and are making breast milk or breastfeeding when you join.
  • You previously had drugs targeting all KRAS types or KRAS G12D, unless testing after that treatment confirmed your cancer still has KRAS G12D.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (18)

CA

FL

IL

KS

MA

MO

NY

OR

PA

TN

TX

WI