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Brief Title: Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)
Official Title: A Phase 2 Multi-center Open-label Basket Trial of Nab-sirolimus for Adult and Adolescent Patients With Malignant Solid Tumors Harboring Pathogenic Inactivating Alterations in TSC1 or TSC2 Genes.
Study ID: NCT05103358
Brief Summary: A Phase 2 multi-center open-label basket trial of nab-sirolimus for adult and adolescent patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes
Detailed Description: Study TSC-007 is a prospective phase 2, open-label, multi-institutional basket trial to determine the efficacy and safety profile of nab-sirolimus administered to patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes. Patients will be treated with single agent IV nab-sirolimus until disease progression, or unacceptable toxicity, or until in the opinion of the investigator the patient is no longer benefiting from therapy, or at patient discretion.
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Alabama Oncology, Birmingham, Alabama, United States
Southern Cancer Center, Mobile, Alabama, United States
Arizona Oncology Associates, Goodyear, Arizona, United States
Honor Health, Phoenix, Arizona, United States
Arizona Oncology Associates, Prescott Valley, Arizona, United States
Yuma Regional Medical Center, Yuma, Arizona, United States
PCR Oncology, Arroyo Grande, California, United States
Nextgen Oncology, Beverly Hills, California, United States
City of Hope, Duarte, California, United States
Providence Medical Foundation (Fullerton), Fullerton, California, United States
MemorialCare, Long Beach, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
UCLA - Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
Providence Medical Foundation (Napa), Napa, California, United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
Sharp HealthCare, San Diego, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Ridley-Tree Cancer Center, Santa Barbara, California, United States
Sarcoma Oncology Research Center, Santa Monica, California, United States
Providence Medical Foundation, Santa Rosa, California, United States
Stanford Cancer Center, Stanford, California, United States
The Oncology Institute of Hope & Innovation, Whittier, California, United States
Rocky Mountain Cancer Centers, Aurora, Colorado, United States
Rocky Mountain Cancer Centers, Boulder, Colorado, United States
Rocky Mountain Cancer Centers, Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers (Williams St), Denver, Colorado, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Rocky Mountain Cancer Centers, Lakewood, Colorado, United States
Rocky Mountain Cancer Centers, Littleton, Colorado, United States
Rocky Mountain Cancer Centers, Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers, Longmont, Colorado, United States
Rocky Mountain Cancer Centers, Pueblo, Colorado, United States
Rocky Mountain Cancer Centers, Thornton, Colorado, United States
Hartford Healthcare, Hartford, Connecticut, United States
Eastern Connecticut Hematology and Oncology, Norwich, Connecticut, United States
Florida Cancer Specialists - North Division, Altamonte Springs, Florida, United States
Florida Cancer Specialists - South Division, Bonita Springs, Florida, United States
Florida Cancer Specialists - South Division, Bradenton, Florida, United States
Florida Cancer Specialists - South Division, Bradenton, Florida, United States
Florida Cancer Specialists - North Division, Brandon, Florida, United States
Florida Cancer Specialists - South Division, Cape Coral, Florida, United States
Florida Cancer Specialists - North Division, Clearwater, Florida, United States
Cancer Specialist - East, Daytona Beach, Florida, United States
Holy Cross Hospital, Fort Lauderdale, Florida, United States
Florida Cancer Specialists South Division, Fort Myers, Florida, United States
Florida Cancer Specialists - South, Fort Myers, Florida, United States
Florida Cancer Specialists - South, Fort Myers, Florida, United States
Florida Cancer Specialists - North Division, Gainesville, Florida, United States
Cancer Specialists of North Florida, Jacksonville, Florida, United States
The Oncology Institute of Hope and Innovation, Lakeland, Florida, United States
TOI Florida, Lakeland, Florida, United States
Florida Cancer Specialists - North Division, Largo, Florida, United States
Florida Cancer Specialists - North Division, Lecanto, Florida, United States
Florida Cancer Specialists - South Division, Naples, Florida, United States
Florida Cancer Specialists - North Division, Ocala, Florida, United States
Ocala Oncology, Ocala, Florida, United States
Florida Cancer Specialists - North Division, Orange City, Florida, United States
Florida Cancer Specialists - North Division, Orlando, Florida, United States
Florida Cancer Specialists - South Division, Port Charlotte, Florida, United States
Florida Cancer Specialists and Research Institute - North Division, Saint Petersburg, Florida, United States
Florida Cancer Specialists - North, Saint Petersburg, Florida, United States
Florida Cancer Specialists - South Division, Sarasota, Florida, United States
Florida Cancer Specialists - South Division, Sarasota, Florida, United States
Florida Cancer Specialist - East, Stuart, Florida, United States
Florida Cancer Specialists - North Division, Tampa, Florida, United States
Florida Cancer Specialists - North Division, Tavares, Florida, United States
Florida Cancer Specialists - North Division, Trinity, Florida, United States
Florida Cancer Specialists - South Division, Venice, Florida, United States
Florida Cancer Specialists - South Division, Venice, Florida, United States
Florida Cancer Specialists - East, Vero Beach, Florida, United States
Florida Cancer Specialists - East, Wellington, Florida, United States
Florida Cancer Specialists - East, West Palm Beach, Florida, United States
Morehouse School of Medicine, Atlanta, Georgia, United States
Hawaii Cancer Center, Honolulu, Hawaii, United States
Hope and Healing Cancer Services, Hinsdale, Illinois, United States
Northwest Oncology and Hematology, Rolling Meadows, Illinois, United States
Urology of Indiana, Carmel, Indiana, United States
Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
Goshen Health, Goshen, Indiana, United States
Our Lady of the Lake, Baton Rouge, Louisiana, United States
Pontchartrain, Hammond, Louisiana, United States
American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders), Bethesda, Maryland, United States
Frederick Health, Frederick, Maryland, United States
Maryland Oncology Hematology, Rockville, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Southcoast Centers for Cancer Care, Fairhaven, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Sparrow Hospital, Lansing, Michigan, United States
Minnesota Oncology Hematology, Minneapolis, Minnesota, United States
Central Care Cancer Center, Bolivar, Missouri, United States
Lake Regional, Osage Beach, Missouri, United States
Mosaic Life Care, Saint Joseph, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Oncology Hematology Associates, Springfield, Missouri, United States
Nebraska Cancer Specialists, Grand Island, Nebraska, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
OptumCare Cancer Care-Parent, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
New Jersey Cancer Care and Blood Disorders, Belleville, New Jersey, United States
Englewood Hospital and Medical Center, Englewood, New Jersey, United States
Summit Medical Group - NJ, Florham Park, New Jersey, United States
Atlantic Health System - Morristown Medical Center, Morristown, New Jersey, United States
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
HOACNY, East Syracuse, New York, United States
Cayuga Medical Center, Ithaca, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, New York, United States
Southeastern Medical Oncology, Goldsboro, North Carolina, United States
Sanford Health-Fargo, Fargo, North Dakota, United States
Aultman Medical Group, Canton, Ohio, United States
TriHealth, Cincinnati, Ohio, United States
University of Cincinnati (UC) - Cancer Institute, Cincinnati, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
The Toledo Clinic, Toledo, Ohio, United States
Oklahoma State University (OSU) - Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialist, Tulsa, Oklahoma, United States
Gettysburg-PCSRI, Gettysburg, Pennsylvania, United States
Alliance Cancer Specialists, Langhorne, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Cancer Care Associates of York - Parent, York, Pennsylvania, United States
Prisma Health Cancer Institute, Greenville, South Carolina, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Sanford Health, Sioux Falls, South Dakota, United States
Sarah Cannon and HCA Research Institute, Dickson, Tennessee, United States
Sarah Cannon and HCA Research Institute, Franklin, Tennessee, United States
Sarah Cannon and HCA Research Institute, Gallatin, Tennessee, United States
West Cancer Center, Germantown, Tennessee, United States
Sarah Cannon and HCA Research Institute, Henderson, Tennessee, United States
Sarah Cannon and HCA Research Institute, Hermitage, Tennessee, United States
Sarah Cannon and HCA Research Institute, Lebanon, Tennessee, United States
Baptist Cancer Center, Memphis, Tennessee, United States
Sarah Cannon and HCA Research Institute, Murfreesboro, Tennessee, United States
Sarah Cannon and HCA Research Institute, Nashville, Tennessee, United States
Sarah Cannon and HCA Research Institute, Nashville, Tennessee, United States
Sarah Cannon and HCA Research Institute, Nashville, Tennessee, United States
Sarah Cannon and HCA Research Institute, Nashville, Tennessee, United States
Sarah Cannon and HCA Research Institute, Shelbyville, Tennessee, United States
Sarah Cannon and HCA Research Institute, Smyrna, Tennessee, United States
Mary Crowley Cancer Research, Dallas, Texas, United States
Texas Oncology - DFW, Dallas, Texas, United States
Texas Oncology, El Paso, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Oncology Consultants, Houston, Texas, United States
Arizona Oncology Associates, Irving, Texas, United States
Lumi Research, Kingwood, Texas, United States
Texas Oncology Central-South, McAllen, Texas, United States
South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, United States
Texas Oncology, Tyler, Texas, United States
Community Cancer Trials of Utah, Ogden, Utah, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Hematology Oncology Associates of Fredericksburg, Fredericksburg, Virginia, United States
Virginia Urology, Richmond, Virginia, United States
University of Washington Cancer Consortium, Seattle, Washington, United States
Spokane Urology, Spokane, Washington, United States
Cancer Care Northwest, Spokane, Washington, United States
Northwest Medical Specialties, Tacoma, Washington, United States
ThedaCare, Appleton, Wisconsin, United States
Gunderson Health System, La Crosse, Wisconsin, United States
University of Wisconsin - Carbone Cancer Center, Madison, Wisconsin, United States
Inje University Haeundae Paik Hospital, Busan, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Pan Oncology Trials, LLC, San Juan, , Puerto Rico