Phase
Condition
Endometriosis
Cancer/tumors
Vaginal Cancer
Treatment
AZD0240: Autologous, engineered T Cells targeting KRAS G12D
NT-112: Autologous, engineered T Cells targeting KRAS G12D
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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-C08:02positive, HLA-A11:01 or HLA-A*11:02 positive in at least one allele
Subject has advanced solid cancer, defined as unresectable, advanced, and/ormetastatic disease (Stage III or IV) after at least 1 line of approved systemicstandard of care (SOC) treatment regimen and for which there are no availablecurative 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 timeof enrollment
Exclusion
Key Exclusion Criteria:
Any other primary malignancy within the 3 years prior to enrollment (except fornon-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) orlow-grade prostate cancer
Known, active primary central nervous system (CNS) malignancy
History of prior adoptive cell and gene therapy, allogeneic stem cell transplant orsolid organ transplantation.
History of stroke or transient ischemic attack within the 12 months prior toenrollment.
History of clinically significant cardiac disease within the 6 months prior toenrollment 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 otherimmunosuppressive treatment (except if related to prior checkpoint inhibitortherapy)
Female of childbearing potential who is lactating or breast feeding at the time ofenrollment
Prior treatment with pan-KRAS or KRAS G12D targeting agents unless presence of KRASG12D mutation is confirmed after the completion of treatment with pan-KRAS or KRASG12D targeting agents.
Study Design
Study Description
Connect with a study center
City of Hope
Duarte, California 91010
United StatesActive - Recruiting
Research Site
Duarte, California 91010
United StatesActive - Recruiting
Research Site
Los Angeles, California 90095
United StatesActive - Recruiting
UCLA Health Jonsson Comprehensive Cancer Center
Los Angeles, California 90024
United StatesActive - Recruiting
Hoag Hospital Newport Beach
Newport Beach, California 92658
United StatesActive - Recruiting
Research Site
Newport Beach, California 92663
United StatesActive - Recruiting
Research Site
Duarte 5344147, California 5332921 91010
United StatesSite Not Available
Research Site
Los Angeles 5368361, California 5332921 90095
United StatesSite Not Available
Research Site
Newport Beach 5376890, California 5332921 92663
United StatesSite Not Available
Research Site
Jacksonville, Florida 32224
United StatesActive - Recruiting
Research Site
Jacksonville 4160021, Florida 4155751 32224
United StatesSite Not Available
Research Site
Miami 4164138, Florida 4155751 33136
United StatesSite Not Available
Research Site
Chicago, Illinois 60637
United StatesActive - Recruiting
Research Site
Chicago 4887398, Illinois 4896861 60637
United StatesSite Not Available
University of Kansas Cancer Center - Westwood Campus
Fairway, Kansas 66205
United StatesSite Not Available
Research Site
Westwood, Kansas 66205
United StatesActive - Recruiting
Research Site
Westwood 4281639, Kansas 4273857 66205
United StatesSite Not Available
Research Site
Boston, Massachusetts 02115
United StatesActive - Recruiting
Research Site
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine in St. Louis
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Research Site
St Louis, Missouri 63110
United StatesActive - Recruiting
Washington University School of Medicine in St. Louis
St. Louis, Missouri 63110
United StatesSite Not Available
Research Site
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
Research Site
New York, New York 10016
United StatesActive - Recruiting
Research Site
New York 5128581, New York 5128638 10065
United StatesSite Not Available
Providence Portland Medical Center
Portland, Oregon 97213
United StatesSite Not Available
Research Site
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
Research Site
Pittsburgh, Pennsylvania 15237
United StatesActive - Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
Research Site
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesSite Not Available
Research Site
Pittsburgh 5206379, Pennsylvania 6254927 15237
United StatesSite Not Available
Research Site
Nashville, Tennessee 37203
United StatesActive - Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesActive - Recruiting
Research Site
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
Baylor Scott & White Health / Texas Oncology, PA
Dallas, Texas 75246
United StatesActive - Recruiting
Research Site
Dallas, Texas 75246
United StatesActive - Recruiting
Research Site
Galveston, Texas 77555
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
Research Site
Houston, Texas 77030
United StatesActive - Recruiting
Research Site
Dallas 4684888, Texas 4736286 75246
United StatesSite Not Available
Research Site
Galveston 4692883, Texas 4736286 77555
United StatesSite Not Available
Research Site
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Research Site
Aberdeen, Washington 98520
United StatesActive - Recruiting
Research Site
Aberdeen 5785243, Washington 5815135 98520
United StatesSite Not Available
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
Research Site
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
Research Site
Milwaukee 5263045, Wisconsin 5279468 53226
United StatesSite Not Available

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