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ACTIVE NOT RECRUITING

NCT05103358

PHASE2

Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)

Sponsor: Aadi Bioscience, Inc.

View on ClinicalTrials.gov

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

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.

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2022-02-15

Completion Date

2025-12-31

Last Updated

2024-06-03

Healthy Volunteers

Interventions

DRUG

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

Inclusion Criteria: 1. Patients must have a malignant solid tumor with a pathogenic inactivating TSC1 or TSC2 alteration. Genetic alterations should be identified using NGS in tumor tissue or liquid biopsy). • 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: 1. Prior treatment with an mTOR inhibitor, including nab-sirolimus. 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.

Locations (166)

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