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Fase 2-kurveforsøg med Nab-sirolimus hos patienter med ondartede solide tumorer med patogene ændringer i TSC1- eller TSC2-gener (PRÆCISION 1)

26. oktober 2026 opdateret af: Aadi Bioscience, Inc.

Et fase 2 multicenter åbent basket forsøg med Nab-sirolimus til voksne og unge patienter med ondartede solide tumorer, der rummer patogene inaktiverende ændringer i TSC1- eller TSC2-gener

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

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Afsluttet

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

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.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Faktiske)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
128

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35243
        • Alabama Oncology
      • Mobile, Alabama, Forenede Stater, 36607
        • Southern Cancer Center
    • Arizona
      • Goodyear, Arizona, Forenede Stater, 85395
        • Arizona Oncology Associates
      • Phoenix, Arizona, Forenede Stater, 85016
        • Honor Health
      • Prescott Valley, Arizona, Forenede Stater, 86301
        • Arizona Oncology Associates
      • Yuma, Arizona, Forenede Stater, 85364
        • Yuma Regional Medical Center
    • California
      • Arroyo Grande, California, Forenede Stater, 93420
        • PCR Oncology
      • Beverly Hills, California, Forenede Stater, 90212
        • Nextgen Oncology
      • Duarte, California, Forenede Stater, 91010
        • City of Hope
      • Fullerton, California, Forenede Stater, 92835
        • Providence Medical Foundation (Fullerton)
      • Long Beach, California, Forenede Stater, 90806
        • MemorialCare
      • Los Angeles, California, Forenede Stater, 90033
        • USC Norris Comprehensive Cancer Center
      • Los Angeles, California, Forenede Stater, 90095
        • UCLA - Jonsson Comprehensive Cancer Center
      • Napa, California, Forenede Stater, 94558
        • Providence Medical Foundation (Napa)
      • Newport Beach, California, Forenede Stater, 92663
        • Hoag Memorial Hospital Presbyterian
      • San Diego, California, Forenede Stater, 92123
        • Sharp HealthCare
      • San Francisco, California, Forenede Stater, 94115
        • UCSF Helen Diller Family Comprehensive Cancer Center
      • Santa Barbara, California, Forenede Stater, 93105
        • Ridley-Tree Cancer Center
      • Santa Monica, California, Forenede Stater, 90403
        • Sarcoma Oncology Research Center
      • Santa Rosa, California, Forenede Stater, 95403
        • Providence Medical Foundation
      • Stanford, California, Forenede Stater, 94305
        • Stanford Cancer Center
      • Whittier, California, Forenede Stater, 90602
        • The Oncology Institute of Hope & Innovation
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80012
        • Rocky Mountain Cancer Centers
      • Boulder, Colorado, Forenede Stater, 80303
        • Rocky Mountain Cancer Centers
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • Rocky Mountain Cancer Centers
      • Denver, Colorado, Forenede Stater, 80220
        • Rocky Mountain Cancer Centers
      • Denver, Colorado, Forenede Stater, 80218
        • Rocky Mountain Cancer Centers (Williams St)
      • Lakewood, Colorado, Forenede Stater, 80228
        • Rocky Mountain Cancer Centers
      • Littleton, Colorado, Forenede Stater, 80120
        • Rocky Mountain Cancer Centers
      • Lone Tree, Colorado, Forenede Stater, 80124
        • Rocky Mountain Cancer Centers
      • Longmont, Colorado, Forenede Stater, 80501
        • Rocky Mountain Cancer Centers
      • Pueblo, Colorado, Forenede Stater, 81008
        • Rocky Mountain Cancer Centers
      • Thornton, Colorado, Forenede Stater, 80260
        • Rocky Mountain Cancer Centers
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06102
        • Hartford Healthcare
      • Norwich, Connecticut, Forenede Stater, 06360
        • Eastern Connecticut Hematology and Oncology
    • Florida
      • Altamonte Springs, Florida, Forenede Stater, 32701
        • Florida Cancer Specialists - North Division
      • Bonita Springs, Florida, Forenede Stater, 34135
        • Florida Cancer Specialists - South Division
      • Bradenton, Florida, Forenede Stater, 34205
        • Florida Cancer Specialists - South Division
      • Bradenton, Florida, Forenede Stater, 34211
        • Florida Cancer Specialists - South Division
      • Brandon, Florida, Forenede Stater, 33511
        • Florida Cancer Specialists - North Division
      • Cape Coral, Florida, Forenede Stater, 33909
        • Florida Cancer Specialists - South Division
      • Clearwater, Florida, Forenede Stater, 33761
        • Florida Cancer Specialists - North Division
      • Daytona Beach, Florida, Forenede Stater, 32117
        • Cancer Specialist - East
      • Fort Lauderdale, Florida, Forenede Stater, 33308
        • Holy Cross Hospital
      • Fort Myers, Florida, Forenede Stater, 33901
        • Florida Cancer Specialists South Division
      • Fort Myers, Florida, Forenede Stater, 33905
        • Florida Cancer Specialists - South
      • Fort Myers, Florida, Forenede Stater, 33908
        • Florida Cancer Specialists - South
      • Gainesville, Florida, Forenede Stater, 32605
        • Florida Cancer Specialists - North Division
      • Jacksonville, Florida, Forenede Stater, 32256
        • Cancer Specialists of North Florida
      • Lakeland, Florida, Forenede Stater, 33812
        • TOI Florida
      • Lakeland, Florida, Forenede Stater, 33812
        • The Oncology Institute of Hope and Innovation
      • Largo, Florida, Forenede Stater, 33770
        • Florida Cancer Specialists - North Division
      • Lecanto, Florida, Forenede Stater, 34461
        • Florida Cancer Specialists - North Division
      • Naples, Florida, Forenede Stater, 34102
        • Florida Cancer Specialists - South Division
      • Ocala, Florida, Forenede Stater, 34474
        • Ocala Oncology
      • Ocala, Florida, Forenede Stater, 34474
        • Florida Cancer Specialists - North Division
      • Orange City, Florida, Forenede Stater, 32763
        • Florida Cancer Specialists - North Division
      • Orlando, Florida, Forenede Stater, 32806
        • Florida Cancer Specialists - North Division
      • Port Charlotte, Florida, Forenede Stater, 33980
        • Florida Cancer Specialists - South Division
      • Sarasota, Florida, Forenede Stater, 34232
        • Florida Cancer Specialists - South Division
      • Sarasota, Florida, Forenede Stater, 34236
        • Florida Cancer Specialists - South Division
      • St. Petersburg, Florida, Forenede Stater, 33705
        • Florida Cancer Specialists and Research Institute - North Division
      • St. Petersburg, Florida, Forenede Stater, 33707
        • Florida Cancer Specialists - North
      • Stuart, Florida, Forenede Stater, 34994
        • Florida Cancer Specialist - East
      • Tampa, Florida, Forenede Stater, 33607
        • Florida Cancer Specialists - North Division
      • Tavares, Florida, Forenede Stater, 32778
        • Florida Cancer Specialists - North Division
      • Trinity, Florida, Forenede Stater, 34655
        • Florida Cancer Specialists - North Division
      • Venice, Florida, Forenede Stater, 34285
        • Florida Cancer Specialists - South Division
      • Venice, Florida, Forenede Stater, 34292
        • Florida Cancer Specialists - South Division
      • Vero Beach, Florida, Forenede Stater, 32960
        • Florida Cancer Specialists - East
      • Wellington, Florida, Forenede Stater, 33414
        • Florida Cancer Specialists - East
      • West Palm Beach, Florida, Forenede Stater, 33401
        • Florida Cancer Specialists - East
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30303
        • Morehouse School of Medicine
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Hawaii Cancer Center
    • Illinois
      • Hinsdale, Illinois, Forenede Stater, 60521
        • Hope and Healing Cancer Services
      • Rolling Meadows, Illinois, Forenede Stater, 60008
        • Northwest Oncology and Hematology
    • Indiana
      • Carmel, Indiana, Forenede Stater, 46032
        • Urology of Indiana
      • Fort Wayne, Indiana, Forenede Stater, 46804
        • Fort Wayne Medical Oncology and Hematology
      • Goshen, Indiana, Forenede Stater, 46526
        • Goshen Health
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70817
        • Our Lady of the Lake
      • Hammond, Louisiana, Forenede Stater, 70403
        • Pontchartrain
    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20817
        • American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)
      • Frederick, Maryland, Forenede Stater, 21702
        • Frederick Health
      • Rockville, Maryland, Forenede Stater, 20850
        • Maryland Oncology Hematology
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Dana Farber Cancer Institute
      • Fairhaven, Massachusetts, Forenede Stater, 02719
        • Southcoast Centers for Cancer Care
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Barbara Ann Karmanos Cancer Institute
      • Lansing, Michigan, Forenede Stater, 48912
        • Sparrow Hospital
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55404
        • Minnesota Oncology Hematology
    • Missouri
      • Bolivar, Missouri, Forenede Stater, 65613
        • Central Care Cancer Center
      • Osage Beach, Missouri, Forenede Stater, 65065
        • Lake Regional
      • Saint Joseph, Missouri, Forenede Stater, 64507
        • Mosaic Life Care
      • Springfield, Missouri, Forenede Stater, 65807
        • Oncology Hematology Associates
      • St Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
    • Nebraska
      • Grand Island, Nebraska, Forenede Stater, 68803
        • Nebraska Cancer Specialists
      • Omaha, Nebraska, Forenede Stater, 68114
        • Nebraska Methodist Hospital
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89169
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Forenede Stater, 89102
        • OptumCare Cancer Care-Parent
    • New Jersey
      • Belleville, New Jersey, Forenede Stater, 07109
        • New Jersey Cancer Care and Blood Disorders
      • Englewood, New Jersey, Forenede Stater, 07631
        • Englewood Hospital and Medical Center
      • Florham Park, New Jersey, Forenede Stater, 07932
        • Summit Medical Group - NJ
      • Morristown, New Jersey, Forenede Stater, 07960
        • Atlantic Health System - Morristown Medical Center
    • New York
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Comprehensive Cancer Center
      • East Syracuse, New York, Forenede Stater, 13057
        • HOACNY
      • Ithaca, New York, Forenede Stater, 14850
        • Cayuga Medical Center
      • New York, New York, Forenede Stater, 10065
        • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Southeastern Medical Oncology
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58102
        • Sanford Health-Fargo
    • Ohio
      • Canton, Ohio, Forenede Stater, 44708
        • Aultman Medical Group
      • Cincinnati, Ohio, Forenede Stater, 45220
        • TriHealth
      • Cincinnati, Ohio, Forenede Stater, 45627
        • University of Cincinnati (UC) - Cancer Institute
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic
      • Toledo, Ohio, Forenede Stater, 43623
        • The Toledo Clinic
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Oklahoma State University (OSU) - Stephenson Cancer Center
      • Tulsa, Oklahoma, Forenede Stater, 74146
        • Oklahoma Cancer Specialist
    • Pennsylvania
      • Gettysburg, Pennsylvania, Forenede Stater, 17325
        • Gettysburg-PCSRI
      • Langhorne, Pennsylvania, Forenede Stater, 19047
        • Alliance Cancer Specialists
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Thomas Jefferson University
      • York, Pennsylvania, Forenede Stater, 17403
        • Cancer Care Associates of York - Parent
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29605
        • Prisma Health Cancer Institute
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, Forenede Stater, 57117
        • Sanford Health
    • Tennessee
      • Dickson, Tennessee, Forenede Stater, 37055
        • Sarah Cannon and HCA Research Institute
      • Franklin, Tennessee, Forenede Stater, 37067
        • Sarah Cannon and HCA Research Institute
      • Gallatin, Tennessee, Forenede Stater, 37066
        • Sarah Cannon and HCA Research Institute
      • Germantown, Tennessee, Forenede Stater, 38138
        • West Cancer Center
      • Henderson, Tennessee, Forenede Stater, 37075
        • Sarah Cannon and HCA Research Institute
      • Hermitage, Tennessee, Forenede Stater, 37076
        • Sarah Cannon and HCA Research Institute
      • Lebanon, Tennessee, Forenede Stater, 37090
        • Sarah Cannon and HCA Research Institute
      • Memphis, Tennessee, Forenede Stater, 38120
        • Baptist Cancer Center
      • Murfreesboro, Tennessee, Forenede Stater, 37129
        • Sarah Cannon and HCA Research Institute
      • Nashville, Tennessee, Forenede Stater, 37203
        • Sarah Cannon and HCA Research Institute
      • Nashville, Tennessee, Forenede Stater, 37205
        • Sarah Cannon and HCA Research Institute
      • Nashville, Tennessee, Forenede Stater, 37207
        • Sarah Cannon and HCA Research Institute
      • Nashville, Tennessee, Forenede Stater, 37211
        • Sarah Cannon and HCA Research Institute
      • Shelbyville, Tennessee, Forenede Stater, 37160
        • Sarah Cannon and HCA Research Institute
      • Smyrna, Tennessee, Forenede Stater, 37167
        • Sarah Cannon and HCA Research Institute
    • Texas
      • Dallas, Texas, Forenede Stater, 75230
        • Mary Crowley Cancer Research
      • Dallas, Texas, Forenede Stater, 75246
        • Texas Oncology - DFW
      • El Paso, Texas, Forenede Stater, 79915
        • Texas Oncology
      • Houston, Texas, Forenede Stater, 77030
        • MD Anderson Cancer Center
      • Houston, Texas, Forenede Stater, 77030
        • Oncology Consultants
      • Irving, Texas, Forenede Stater, 75063
        • Arizona Oncology Associates
      • Kingwood, Texas, Forenede Stater, 77339
        • Lumi Research
      • McAllen, Texas, Forenede Stater, 78503
        • Texas Oncology Central-South
      • San Antonio, Texas, Forenede Stater, 78229
        • South Texas Accelerated Research Therapeutics (START)
      • Tyler, Texas, Forenede Stater, 75702
        • Texas Oncology
    • Utah
      • Ogden, Utah, Forenede Stater, 84405
        • Community Cancer Trials of Utah
      • Salt Lake City, Utah, Forenede Stater, 84106
        • Utah Cancer Specialists
    • Virginia
      • Fairfax, Virginia, Forenede Stater, 22031
        • Virginia Cancer Specialists
      • Fredericksburg, Virginia, Forenede Stater, 22408
        • Hematology Oncology Associates of Fredericksburg
      • Richmond, Virginia, Forenede Stater, 23235
        • Virginia Urology
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • University of Washington Cancer Consortium
      • Spokane, Washington, Forenede Stater, 99216
        • Cancer Care Northwest
      • Spokane, Washington, Forenede Stater, 99202
        • Spokane Urology
      • Tacoma, Washington, Forenede Stater, 98405
        • Northwest Medical Specialties
    • Wisconsin
      • Appleton, Wisconsin, Forenede Stater, 54911
        • ThedaCare
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gunderson Health System
      • Madison, Wisconsin, Forenede Stater, 53705
        • University of Wisconsin - Carbone Cancer Center
  • Puerto Rico
    • Puerto Rico
      • San Juan, Puerto Rico, Puerto Rico, 00935
        • Pan Oncology Trials, LLC
  • Sydkorea
      • Busan, Sydkorea, 48108
        • Inje University Haeundae Paik Hospital
      • Seoul, Sydkorea, 03080
        • Seoul National University Hospital
      • Seoul, Sydkorea, 05505
        • Asan Medical Center
      • Seoul, Sydkorea, 06351
        • Samsung Medical Center
      • Seoul, Sydkorea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Sydkorea, 08308
        • Korea University Guro Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

12 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Arm A: Pathogenic inactivating TSC1 alterations

Patients with pathogenic inactivating TSC1 alterations.
Medicin: 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

Andre navne:
  • ABI-009
Eksperimentel: Arm B: Pathogenic inactivating TSC2 alterations

Patients with pathogenic inactivating TSC2 alterations.
Medicin: 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

Andre navne:
  • ABI-009

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Response Rate (ORR)
Tidsramme: The first response assessment is done 6 weeks (±7 days) after first treatment and should be repeated every 6 weeks (±7 days) for the first year, then every 12 weeks (±7 days) thereafter until disease progression , up to 30 months.

Based on CT or MRI scans from the time of study treatment initiation until disease progression, overall response rate (ORR) is defined as the proportion of patients with best overall response (BOR) of confirmed partial response (PR) or complete response (CR) in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by independent Radiographic Review (IRR).

CR is defined as disappearance of all target lesions. PR is defined as ≥30% decrease in the sum of diameters of target lesions from baseline, with no new lesions and no progression of non-target lesions.
The first response assessment is done 6 weeks (±7 days) after first treatment and should be repeated every 6 weeks (±7 days) for the first year, then every 12 weeks (±7 days) thereafter until disease progression , up to 30 months.

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration of Response (DOR)
Tidsramme: The first response assessment is done 6 weeks (±7 days) after first treatment and should be repeated every 6 weeks (±7 days) for the first year, then every 12 weeks (±7 days) thereafter until disease progression.

DOR is defined as the number of months from the start of CR or PR (whichever response is recorded first) and subsequently confirmed to the first date of documented progressive disease (PD) or death using CT or MRI scans in accordance with RECIST v1.1.

CR is defined as disappearance of all target lesions. PR is defined as ≥30% decrease in the sum of diameters of target lesions from baseline, with no new lesions and no progression of non-target lesions.

PD is defined as ≥20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
The first response assessment is done 6 weeks (±7 days) after first treatment and should be repeated every 6 weeks (±7 days) for the first year, then every 12 weeks (±7 days) thereafter until disease progression.
Disease Control Rate
Tidsramme: The first response assessment is done 6 weeks (±7 days) after first treatment and should be repeated every 6 weeks (±7 days) for the first year, then every 12 weeks (±7 days) thereafter until disease progression, up to 30 months.

Disease control rate (DCR) is defined as BOR of confirmed CR or PR (either of any duration) or SD ≥12 weeks following study treatment initiation.

CR is defined as disappearance of all target lesions. PR is defined as ≥30% decrease in the sum of diameters of target lesions from baseline, with no new lesions and no progression of non-target lesions.
The first response assessment is done 6 weeks (±7 days) after first treatment and should be repeated every 6 weeks (±7 days) for the first year, then every 12 weeks (±7 days) thereafter until disease progression, up to 30 months.
Time to Response
Tidsramme: The first response assessment is done 6 weeks (±7 days) after first treatment and should be repeated every 6 weeks (±7 days) for the first year, then every 12 weeks (±7 days) thereafter until disease progression.

Time to response (TTR) is defined as the time from first dose of study drug to initial measurement of CR or PR, where CR or PR is subsequently confirmed.

CR is defined as disappearance of all target lesions. PR is defined as ≥30% decrease in the sum of diameters of target lesions from baseline, with no new lesions and no progression of non-target lesions.
The first response assessment is done 6 weeks (±7 days) after first treatment and should be repeated every 6 weeks (±7 days) for the first year, then every 12 weeks (±7 days) thereafter until disease progression.
Progression-free Survival
Tidsramme: From first dose of study treatment to the date of disease progression or death

Number of months from study treatment initiation to the date of disease progression (PD) or death due to any cause PD is defined as ≥20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
From first dose of study treatment to the date of disease progression or death
Overall Survival
Tidsramme: From first dose of study treatment to the date of death

Number of months from study treatment initiation to the date of death due to any cause
From first dose of study treatment to the date of death
Patient-Reported Outcome
Tidsramme: D1 of every cycle up to Cycle 24

Changes from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QOQ-C30) v3.0 scores EORTC QOQ-C30 includes functional scales (physical, role, cognitive, emotional, social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); two used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life.
D1 of every cycle up to Cycle 24
Incidence and Severity of Treatment-emergent and Treatment-related Adverse Events (AEs)
Tidsramme: Monitored continuously from signing of Informed Consent until last dose of IP (estimated up to 30 months) plus safety follow-up of 28 days after the last dose.

Incidence and severity of treatment-emergent and treatment-related AEs as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Monitored continuously from signing of Informed Consent until last dose of IP (estimated up to 30 months) plus safety follow-up of 28 days after the last dose.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Aadi Bioscience, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
10. marts 2022

Primær færdiggørelse (Faktiske)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
23. december 2024

Studieafslutning (Faktiske)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
23. december 2024

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
22. oktober 2021

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
22. oktober 2021

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
2. november 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
28. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
26. oktober 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • TSC-007

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ja

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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