Phase
Condition
Prostate Cancer
Prostate Cancer, Early, Recurrent
Prostate Disorders
Treatment
CLSP-1025
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Patients must be at least 18 years of age at the time of signing the informedconsent.
Patients must be willing and able to provide written informed consent
Patients must have locally advanced or metastatic solid tumors that have progressedafter standard of care therapy or for which no standard therapy exists
Tumors must harbor a TP53 R175H variant mutation confirmed by an accreditedlaboratory-based test
Patients must be HLA-A*02:01 positive by central assay
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the timeof enrollment
Adequate hematological, renal and hepatic function
Per Investigator judgement, patient is willing and able to complete study visitsand/or procedures per the protocol and comply with study requirements for studyparticipation
Exclusion
Key Exclusion Criteria:
Patients with Li-Fraumeni syndrome or other known germline p53 R175H mutation
Patients who have received other p53 R175H-directed therapies
Patients who have not fully recovered from adverse events due to previous anticancertherapies
Patients with active infection requiring systemic antimicrobial therapy
Any other primary malignancy within the 2 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or prostatecancer in remission.
Known active central nervous system metastases and/or carcinomatous meningitis
Study Design
Study Description
Connect with a study center
HonorHealth Research Institute
Scottsdale, Arizona 85258
United StatesSite Not Available
HonorHealth Research Institute
Scottsdale 5313457, Arizona 5551752 85258
United StatesActive - Recruiting
The University of Arizona Cancer Center
Tucson 5318313, Arizona 5551752 85719
United StatesActive - Recruiting
USC - Norris Comprehensive Cancer Center
Los Angeles, California 90033
United StatesSite Not Available
University of California San Francisco
San Francisco, California 94143
United StatesSite Not Available
USC - Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90033
United StatesActive - Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento 5389489, California 5332921 95817
United StatesActive - Recruiting
University of California San Francisco
San Francisco 5391959, California 5332921 94143
United StatesActive - Recruiting
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United StatesSite Not Available
University of Miami - Sylvester Comprehensive Cancer Center
Miami 4164138, Florida 4155751 33136
United StatesActive - Recruiting
The University of Chicago Comprehensive Cancer Center
Chicago 4887398, Illinois 4896861 60637
United StatesActive - Recruiting
University of Kentucky Markey Cancer Center
Lexington, Kentucky 40536
United StatesSite Not Available
University of Kentucky Markey Cancer Center
Lexington 4297983, Kentucky 6254925 40536
United StatesActive - Recruiting
Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center
Baltimore 4347778, Maryland 4361885 21287
United StatesActive - Recruiting
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
United StatesActive - Recruiting
NYU Langone Health
New York 5128581, New York 5128638 10016
United StatesActive - Recruiting
Duke Cancer Institute
Durham 4464368, North Carolina 4482348 27701
United StatesActive - Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
Fox Chase Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19111
United StatesActive - Recruiting
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesActive - Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesActive - Recruiting
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee 37203
United StatesSite Not Available
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
United StatesActive - Recruiting
Baylor University Medical Center
Dallas, Texas 75246
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Baylor University Medical Center
Dallas 4684888, Texas 4736286 75246
United StatesActive - Recruiting
Mary Crowley Cancer Research
Dallas 4684888, Texas 4736286 75230
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135 98109
United StatesActive - Recruiting

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