This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06218914
Recruitment Status : Recruiting
First Posted : January 23, 2024
Last Update Posted : April 2, 2024
Sponsor:
Information provided by (Responsible Party):
Neogene Therapeutics, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Colorectal Carcinoma Pancreatic Ductal Adenocarcinoma Endometrial Cancer Solid Tumor, Adult KRAS G12D Biological: NT-112: Autologous, engineered T Cells targeting KRAS G12D Phase 1

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Phase 1, Multicenter Study to Evaluate the Safety and Preliminary Anti-tumor Activity of NT-112 in Human Leukocyte Antigen-C*08:02-Positive Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors That Are Positive for the KRAS G12D Mutation
Actual Study Start Date : February 5, 2024
Estimated Primary Completion Date : August 30, 2025
Estimated Study Completion Date : January 2, 2040
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: NT-112
Dose Escalation of NT-112.
 Biological: NT-112: Autologous, engineered T Cells targeting KRAS G12D
  • Pre-conditioning by non-myeloablative chemotherapy with fludarabine and cyclophosphamide
  • Single infusion of T cell receptor (TCR) T cells
  • Post-infusion recombinant interleukin-2 (rIL-2)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Evaluate the safety of NT-112 in subjects with unresectable, advanced, and/or metastatic solid tumors; evaluation of Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D(s)) [ Time Frame: 28 days after infusion ]
    Incidence of dose-limiting toxicities

  2. Adverse events and Serious adverse events [ Time Frame: Up to 24 months post-infusion ]
    Incidence of adverse events and serious adverse events by dose level


Secondary Outcome Measures :
  1. Preliminary anti-tumor activity of NT-112 in subjects with unresectable, advanced, and/or metastatic solid tumors [ Time Frame: Up to 24 months post-infusion ]
    Objective Response Rate (ORR) per RECIST V1.1 determined by Investigator assessment.

  2. Preliminary anti-tumor activity of NT-112 in subjects with unresectable, advanced, and/or metastatic solid tumors [ Time Frame: Up to 24 months post-infusion ]
    Best Overall Response (BOR) per RECIST V1.1 determined by Investigator assessment.

  3. Preliminary anti-tumor activity of NT-112 in subjects with unresectable, advanced, and/or metastatic solid tumors [ Time Frame: Up to 24 months post-infusion ]
    Duration of Response (DOR) per RECIST V1.1 determined by Investigator assessment.

  4. Preliminary anti-tumor activity of NT-112 in subjects with unresectable, advanced, and/or metastatic solid tumors [ Time Frame: Up to 24 months post-infusion ]
    Clinical Benefit Rate (CBR) per RECIST V1.1 determined by Investigator assessment.

  5. Preliminary anti-tumor activity of NT-112 in subjects with unresectable, advanced, and/or metastatic solid tumors [ Time Frame: Up to 24 months post-infusion ]
    Time to Response (TTR) per RECIST V1.1 determined by Investigator assessment.

  6. Preliminary anti-tumor activity of NT-112 in subjects with unresectable, advanced, and/or metastatic solid tumors [ Time Frame: Up to 24 months post-infusion ]
    Progression-free survival (PFS) per RECIST V1.1 determined by Investigator assessment.

  7. Preliminary anti-tumor activity of NT-112 in subjects with unresectable, advanced, and/or metastatic solid tumors [ Time Frame: Up to 24 months post-infusion ]
    Overall survival (OS)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06218914


Contacts
Layout table for location contacts
Contact: Neogene Medical Affairs (310) 742-9929 MedicalAffairs@neogene.com

Locations
Layout table for location information
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Marwan Fakih, MD    626-256-4673    mfakih@coh.org   
Principal Investigator: Marwan Fakih, MD         
United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Salman Punekar, MD    212-731-6228    salman.punekar@nyulangone.org   
Principal Investigator: Salman Punekar, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Meredith Pelster, MD, MSCI       SCRI.DDUReferrals@scri.com   
Sponsors and Collaborators
Neogene Therapeutics, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Neogene Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT06218914    
Other Study ID Numbers: NT-112-301
First Posted: January 23, 2024    Key Record Dates
Last Update Posted: April 2, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neogene Therapeutics, Inc.:
TCR-T cell therapy
KRAS
KRAS G12D
Autologous
PDAC
 NSCLC
Colorectal Cancer
Solid tumors
Pancreatic Ductal Adenocarcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Endometrial Neoplasms
Colorectal Neoplasms
Neoplasms
Neoplasms by Site
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases