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TSC1またはTSC2遺伝子の病原性変化を伴う悪性固形腫瘍患者におけるNab-sirolimusの第2相バスケット試験（PRECISION 1）

2026年10月26日 更新者：Aadi Bioscience, Inc.

TSC1 または TSC2 遺伝子の病原性不活性化変化を有する悪性固形腫瘍を有する成人および青年期の患者に対する Nab-sirolimus の第 2 相多施設非盲検バスケット試験

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

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

128

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

12年歳以上 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Arm A: Pathogenic inactivating TSC1 alterations

Patients with pathogenic inactivating TSC1 alterations.
薬：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

他の名前：
  • ABI-009
実験的：Arm B: Pathogenic inactivating TSC2 alterations

Patients with pathogenic inactivating TSC2 alterations.
薬：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

他の名前：
  • ABI-009

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Overall Response Rate (ORR)
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Duration of Response (DOR)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Aadi Bioscience, Inc.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年3月10日

一次修了 (実際)

2024年12月23日

研究の完了 (実際)

2024年12月23日

試験登録日

最初に提出

2021年10月22日

QC基準を満たした最初の提出物

2021年10月22日

最初の投稿 (実際)

2021年11月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月28日

QC基準を満たした最後の更新が送信されました

2026年10月26日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • TSC-007

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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