Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)
NCT ID: NCT05103358
Last Updated: 2024-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2022-02-15
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A: Pathogenic inactivating TSC1 alterations
Patients with pathogenic inactivating TSC1 alterations.
nab-sirolimus
Prospective phase 2, open-label, multi-institutional basket trial to determine the efficacy and safety of nab-sirolimus administered by IV infusion to patients
Arm B: Pathogenic inactivating TSC2 alterations
Patients with pathogenic inactivating TSC2 alterations.
nab-sirolimus
Prospective phase 2, open-label, multi-institutional basket trial to determine the efficacy and safety of nab-sirolimus administered by IV infusion to patients
Interventions
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nab-sirolimus
Prospective phase 2, open-label, multi-institutional basket trial to determine the efficacy and safety of nab-sirolimus administered by IV infusion to patients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
• Patients will be enrolled after the central evaluation of NGS report confirms eligibility.
2. Patients must have solid tumors that are metastatic or locally advanced where surgical resection is not an option or likely to result in severe morbidity.
3. Patients must have received all standard therapies appropriate for their tumor type and stage of disease or, in the opinion of the Investigator, the patient would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy, or the patient has no satisfactory alternative treatments.
4. Patients must have 1 or more measurable target lesions by computed tomography (CT) scan or magnetic resonance imaging (MRI) (RECIST v1.1).
5. Age: 12 years or older.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or Karnofsky Performance Status (KPS) ≥80 or Lansky play-performance scale for pediatric patients ≥80.
7. Adequate liver function:
1. Total bilirubin ≤1.5 × upper limit of normal (ULN) (unless due to Gilbert's syndrome, then ≤3 × ULN)
2. Aspartate aminotransferase (AST) ≤2.5 × ULN (≤5 × ULN if attributable to liver metastases)
8. Adequate renal function: creatinine clearance ≥30 mL/min, Cockcroft-Gault CCr = ((140-age) × weight\[kg\]) / (72 × SCr\[mL/min\]) × 0.85, if female
9. Adequate hematologic parameters:
1. Absolute neutrophil count (ANC) ≥1.0 × 109/L (growth factor support allowed)
2. Platelet count ≥100,000/mm3 (100 × 109/L) (transfusion and/or growth factor support allowed)
3. Hemoglobin ≥8.0 g/dL (transfusion and/or growth factor support allowed)
10. Fasting serum triglyceride must be ≤300 mg/dL; fasting serum cholesterol must be ≤350 mg/dL.
11. Minimum of 4 weeks since any major surgery, completion of radiation, or completion of prior systemic anticancer therapy, or at least 5 half-lives if the prior therapy is a single agent small-molecule therapeutic, and adequately recovered from the acute toxicities of any prior therapy, including neuropathy, to Grade ≤1.
12. Male or non-pregnant and non-breastfeeding female:
1. Females of childbearing potential must agree to use effective contraception or abstinence without interruption from 28 days prior to starting investigational product (IP) throughout 3 months after last dose of IP and have a negative serum pregnancy test (beta human chorionic gonadotropin, β-hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study treatment. A second form of birth control is required even if she has had a tubal ligation.
2. Male patients must agree not to donate sperm and must practice abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study and throughout 3 months after last dose of IP. A second form of birth control is required even if he has undergone a successful vasectomy.
13. The patient or the patient's parent(s) or legal guardian(s) understand(s) and sign(s) the informed consent.
14. Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures.
Exclusion Criteria
2. Severe (Grade ≥3) ongoing infection requiring parenteral or oral anti-infective treatment, either ongoing or completed ≤7 days prior to enrollment.
3. Patients with primary brain tumors or PEComa.
4. Patients who have any severe and/or uncontrolled medical or psychiatric conditions or other conditions that could affect their participation including:
1. Patients with meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, untreated brain metastases or symptomatic or unstable brain metastases. Note: Patients with stable brain metastases (defined as asymptomatic or no requirement for high-dose \[defined as dexamethasone 10 mg daily or higher\] or increasing dose of systemic corticosteroids) and without imminent need of radiation therapy are eligible. If applicable, patients must have completed brain radiation therapy and recovered adequately from any associated toxicity and/or complications prior to eligibility assessment. For patients who have received prior radiation therapy, post-treatment MRI scan should show no increase in brain lesion size/volume.
2. Unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association, NYHA class III or IV), myocardial infarction ≤6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease.
3. Pre-existing severely impaired lung function. If a patient has a pre-existing pulmonary condition, eligible patients should have a spirometry and diffusing capacity for carbon monoxide (DLCO) that is \>50% of the normal predicted value and/or O2 saturation that is \>88% at rest on room air (Note: spirometry and pulmonary function tests \[PFTs\] not required to be performed unless clinically indicated).
4. Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy.
5. A history of malignancies other than the one under treatment unless the patient is disease-free for more than 5 years from diagnosis. Note, controlled non-melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer, certain low grade hematologic malignancies (eg CLL, follicular lymphoma, etc), or other adequately treated carcinoma-in-situ may be eligible, after discussion with the medical monitor.
6. Uncontrolled hypertension (systolic blood pressure ≥160 mm-Hg and/or diastolic blood pressure ≥100 mm Hg).
7. Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
8. Individuals with known human immunodeficiency virus (HIV) infection are excluded from this study as combination antiretroviral therapy could potentially result in significant pharmacokinetic interactions. In addition, these individuals are at increased risk of serious infections due to the immunosuppressive effects of mTOR inhibition.
9. Active Hepatitis B or Hepatitis C, with detectable viral load.
5. Regarding concomitant medications with significant CYP3A4 and P-gp interactions, discontinuation of strong inhibitors (eg, ketoconazole, itraconazole, voriconazole, erythromycin, clarithromycin, telithromycin, and others), strong inducers (eg, rifampin, rifabutin), and known CYP3A4 substrates with a narrow therapeutic window (eg, fentanyl, alfentanil, astemizole, cisapride, dihydroergotamine, pimozide, quinidine, or terfenadine) is required at least 5 half lives prior to receiving the first dose of nab-sirolimus, whichever is longer.
12 Years
ALL
No
Sponsors
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Aadi Bioscience, Inc.
INDUSTRY
Responsible Party
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Locations
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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 - South Division
Sarasota, Florida, United States
Florida Cancer Specialists - South Division
Sarasota, Florida, United States
Florida Cancer Specialists and Research Institute - North Division
St. Petersburg, Florida, United States
Florida Cancer Specialists - North
St. Petersburg, 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
Oncology Hematology Associates
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, 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
Pan Oncology Trials, LLC
San Juan, , Puerto Rico
Inje University Haeundae Paik Hospital
Busan, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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TSC-007
Identifier Type: -
Identifier Source: org_study_id
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