TumorPhase 2NCT05103358
Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)
A Phase 2 study testing nab-sirolimus in people with Tumor and Tumor, Solid, run by Aadi Bioscience, Inc. at 166 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Tumor, Tumor, Solid, Metastasis
- What is being tested?
- nab-sirolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 166 sitesin 3 countries
- Study dates
- 10 Mar 2022to 23 Dec 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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.
- 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.
- Patients must have 1 or more measurable target lesions by computed tomography (CT) scan or magnetic resonance imaging (MRI) (RECIST v1.1).
- Age: 12 years or older.
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- 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.
- Adequate liver function:
- Total bilirubin ≤1.5 × upper limit of normal (ULN) (unless due to Gilbert's syndrome, then ≤3 × ULN)
- Aspartate aminotransferase (AST) ≤2.5 × ULN (≤5 × ULN if attributable to liver metastases)
- Adequate renal function: creatinine clearance ≥30 mL/min, Cockcroft-Gault CCr = ((140-age) × weight[kg]) / (72 × SCr[mL/min]) × 0.85, if female
- Adequate hematologic parameters:
- Absolute neutrophil count (ANC) ≥1.0 × 109/L (growth factor support allowed)
- Platelet count ≥100,000/mm3 (100 × 109/L) (transfusion and/or growth factor support allowed)
- Hemoglobin ≥8.0 g/dL (transfusion and/or growth factor support allowed)
- Fasting serum triglyceride must be ≤300 mg/dL; fasting serum cholesterol must be ≤350 mg/dL.
- 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.
- Male or non-pregnant and non-breastfeeding female:
- 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.
- 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.
- The patient or the patient's parent(s) or legal guardian(s) understand(s) and sign(s) the informed consent.
- Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures.
Who cannot join
- Prior treatment with an mTOR inhibitor, including nab-sirolimus.
- Severe (Grade ≥3) ongoing infection requiring parenteral or oral anti-infective treatment, either ongoing or completed ≤7 days prior to enrollment.
- Patients with primary brain tumors or PEComa.
- Patients who have any severe and/or uncontrolled medical or psychiatric conditions or other conditions that could affect their participation including:
- 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.
- 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.
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- 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).
- Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy.
- 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.
- Uncontrolled hypertension (systolic blood pressure ≥160 mm-Hg and/or diastolic blood pressure ≥100 mm Hg).
- Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
- 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.
- Active Hepatitis B or Hepatitis C, with detectable viral load.
- 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.
Trial locations and contacts
166 sites in 3 countries.
166 sites in 3 countries
United States159 sites
Florida Cancer Specialists - North Division
Altamonte Springs, Florida, 32701
ThedaCare
Appleton, Wisconsin, 54911
PCR Oncology
Arroyo Grande, California, 93420
Morehouse School of Medicine
Atlanta, Georgia, 30303
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012
Our Lady of the Lake
Baton Rouge, Louisiana, 70817
New Jersey Cancer Care and Blood Disorders
Belleville, New Jersey, 07109
American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)
Bethesda, Maryland, 20817
Nextgen Oncology
Beverly Hills, California, 90212
Alabama Oncology
Birmingham, Alabama, 35243
Central Care Cancer Center
Bolivar, Missouri, 65613
Florida Cancer Specialists - South Division
Bonita Springs, Florida, 34135
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Rocky Mountain Cancer Centers
Boulder, Colorado, 80303
Florida Cancer Specialists - South Division
Bradenton, Florida, 34205
Florida Cancer Specialists - South Division
Bradenton, Florida, 34211
Florida Cancer Specialists - North Division
Brandon, Florida, 33511
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Aultman Medical Group
Canton, Ohio, 44708
Florida Cancer Specialists - South Division
Cape Coral, Florida, 33909
Urology of Indiana
Carmel, Indiana, 46032
TriHealth
Cincinnati, Ohio, 45220
University of Cincinnati (UC) - Cancer Institute
Cincinnati, Ohio, 45627
Florida Cancer Specialists - North Division
Clearwater, Florida, 33761
Cleveland Clinic
Cleveland, Ohio, 44195
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, 80907
Mary Crowley Cancer Research
Dallas, Texas, 75230
Texas Oncology - DFW
Dallas, Texas, 75246
Cancer Specialist - East
Daytona Beach, Florida, 32117
Rocky Mountain Cancer Centers (Williams St)
Denver, Colorado, 80218
Rocky Mountain Cancer Centers
Denver, Colorado, 80220
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Sarah Cannon and HCA Research Institute
Dickson, Tennessee, 37055
City of Hope
Duarte, California, 91010
HOACNY
East Syracuse, New York, 13057
Texas Oncology
El Paso, Texas, 79915
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Southcoast Centers for Cancer Care
Fairhaven, Massachusetts, 02719
Sanford Health-Fargo
Fargo, North Dakota, 58102
Summit Medical Group - NJ
Florham Park, New Jersey, 07932
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Florida Cancer Specialists South Division
Fort Myers, Florida, 33901
Florida Cancer Specialists - South
Fort Myers, Florida, 33905
Florida Cancer Specialists - South
Fort Myers, Florida, 33908
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
Sarah Cannon and HCA Research Institute
Franklin, Tennessee, 37067
Frederick Health
Frederick, Maryland, 21702
Hematology Oncology Associates of Fredericksburg
Fredericksburg, Virginia, 22408
Providence Medical Foundation (Fullerton)
Fullerton, California, 92835
Florida Cancer Specialists - North Division
Gainesville, Florida, 32605
Sarah Cannon and HCA Research Institute
Gallatin, Tennessee, 37066
West Cancer Center
Germantown, Tennessee, 38138
Gettysburg-PCSRI
Gettysburg, Pennsylvania, 17325
Southeastern Medical Oncology
Goldsboro, North Carolina, 27534
Arizona Oncology Associates
Goodyear, Arizona, 85395
Goshen Health
Goshen, Indiana, 46526
Nebraska Cancer Specialists
Grand Island, Nebraska, 68803
Prisma Health Cancer Institute
Greenville, South Carolina, 29605
Pontchartrain
Hammond, Louisiana, 70403
Hartford Healthcare
Hartford, Connecticut, 06102
Sarah Cannon and HCA Research Institute
Henderson, Tennessee, 37075
Sarah Cannon and HCA Research Institute
Hermitage, Tennessee, 37076
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
Hawaii Cancer Center
Honolulu, Hawaii, 96813
MD Anderson Cancer Center
Houston, Texas, 77030
Oncology Consultants
Houston, Texas, 77030
Arizona Oncology Associates
Irving, Texas, 75063
Cayuga Medical Center
Ithaca, New York, 14850
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
Lumi Research
Kingwood, Texas, 77339
Gunderson Health System
La Crosse, Wisconsin, 54601
The Oncology Institute of Hope and Innovation
Lakeland, Florida, 33812
TOI Florida
Lakeland, Florida, 33812
Rocky Mountain Cancer Centers
Lakewood, Colorado, 80228
Alliance Cancer Specialists
Langhorne, Pennsylvania, 19047
Sparrow Hospital
Lansing, Michigan, 48912
Florida Cancer Specialists - North Division
Largo, Florida, 33770
OptumCare Cancer Care-Parent
Las Vegas, Nevada, 89102
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Sarah Cannon and HCA Research Institute
Lebanon, Tennessee, 37090
Florida Cancer Specialists - North Division
Lecanto, Florida, 34461
Rocky Mountain Cancer Centers
Littleton, Colorado, 80120
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124
MemorialCare
Long Beach, California, 90806
Rocky Mountain Cancer Centers
Longmont, Colorado, 80501
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
UCLA - Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
University of Wisconsin - Carbone Cancer Center
Madison, Wisconsin, 53705
Texas Oncology Central-South
McAllen, Texas, 78503
Baptist Cancer Center
Memphis, Tennessee, 38120
Minnesota Oncology Hematology
Minneapolis, Minnesota, 55404
Southern Cancer Center
Mobile, Alabama, 36607
Atlantic Health System - Morristown Medical Center
Morristown, New Jersey, 07960
Sarah Cannon and HCA Research Institute
Murfreesboro, Tennessee, 37129
Providence Medical Foundation (Napa)
Napa, California, 94558
Florida Cancer Specialists - South Division
Naples, Florida, 34102
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, 37203
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, 37205
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, 37207
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, 37211
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Eastern Connecticut Hematology and Oncology
Norwich, Connecticut, 06360
Florida Cancer Specialists - North Division
Ocala, Florida, 34474
Ocala Oncology
Ocala, Florida, 34474
Community Cancer Trials of Utah
Ogden, Utah, 84405
Oklahoma State University (OSU) - Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Florida Cancer Specialists - North Division
Orange City, Florida, 32763
Florida Cancer Specialists - North Division
Orlando, Florida, 32806
Lake Regional
Osage Beach, Missouri, 65065
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Honor Health
Phoenix, Arizona, 85016
Florida Cancer Specialists - South Division
Port Charlotte, Florida, 33980
Arizona Oncology Associates
Prescott Valley, Arizona, 86301
Rocky Mountain Cancer Centers
Pueblo, Colorado, 81008
Virginia Urology
Richmond, Virginia, 23235
Maryland Oncology Hematology
Rockville, Maryland, 20850
Northwest Oncology and Hematology
Rolling Meadows, Illinois, 60008
Mosaic Life Care
Saint Joseph, Missouri, 64507
Utah Cancer Specialists
Salt Lake City, Utah, 84106
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229
Sharp HealthCare
San Diego, California, 92123
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
Ridley-Tree Cancer Center
Santa Barbara, California, 93105
Sarcoma Oncology Research Center
Santa Monica, California, 90403
Providence Medical Foundation
Santa Rosa, California, 95403
Florida Cancer Specialists - South Division
Sarasota, Florida, 34232
Florida Cancer Specialists - South Division
Sarasota, Florida, 34236
University of Washington Cancer Consortium
Seattle, Washington, 98109
Sarah Cannon and HCA Research Institute
Shelbyville, Tennessee, 37160
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Sanford Health
Sioux Falls, South Dakota, 57117
Sarah Cannon and HCA Research Institute
Smyrna, Tennessee, 37167
Spokane Urology
Spokane, Washington, 99202
Cancer Care Northwest
Spokane, Washington, 99216
Oncology Hematology Associates
Springfield, Missouri, 65807
Washington University School of Medicine
St Louis, Missouri, 63110
Florida Cancer Specialists and Research Institute - North Division
St. Petersburg, Florida, 33705
Florida Cancer Specialists - North
St. Petersburg, Florida, 33707
Stanford Cancer Center
Stanford, California, 94305
Florida Cancer Specialist - East
Stuart, Florida, 34994
Northwest Medical Specialties
Tacoma, Washington, 98405
Florida Cancer Specialists - North Division
Tampa, Florida, 33607
Florida Cancer Specialists - North Division
Tavares, Florida, 32778
Rocky Mountain Cancer Centers
Thornton, Colorado, 80260
The Toledo Clinic
Toledo, Ohio, 43623
Florida Cancer Specialists - North Division
Trinity, Florida, 34655
Oklahoma Cancer Specialist
Tulsa, Oklahoma, 74146
Texas Oncology
Tyler, Texas, 75702
Florida Cancer Specialists - South Division
Venice, Florida, 34285
Florida Cancer Specialists - South Division
Venice, Florida, 34292
Florida Cancer Specialists - East
Vero Beach, Florida, 32960
Florida Cancer Specialists - East
Wellington, Florida, 33414
Florida Cancer Specialists - East
West Palm Beach, Florida, 33401
The Oncology Institute of Hope & Innovation
Whittier, California, 90602
Cancer Care Associates of York - Parent
York, Pennsylvania, 17403
Yuma Regional Medical Center
Yuma, Arizona, 85364
South Korea6 sites
Inje University Haeundae Paik Hospital
Busan, 48108
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Korea University Guro Hospital
Seoul, 08308
About this study
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.
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
Read the detailed description
Study TSC-007 is a prospective phase 2, open-label, multi-institutional basket trial to determine the efficacy and safety profile of nab-sirolimus administered to patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes. Patients will be treated with single agent IV nab-sirolimus until disease progression, or unacceptable toxicity, or until in the opinion of the investigator the patient is no longer benefiting from therapy, or at patient discretion.
- Conditions
- Tumor, Tumor, Solid, Metastasis, Metastatic Cancer, Cancer, Cancer Metastatic
- Being tested
- nab-sirolimus
- Keywords
- TSC1 gene, TSC2 gene, Tissue agnostic, Basket, nab-sirolimus, mTOR inhibitor, nanoparticle albumin bound, mammalian target of rapamycin, mechanistic target of rapamycin, tumor profile, tuberous sclerosis complex 1, tuberous sclerosis complex 2, mTOR, sirolimus, TSC1, TSC2, ABI-009, FYARRO, Precision, Precision 1
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Tuberous Sclerosis 1, Tuberous Sclerosis 2, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nab-sirolimusDrug
Also called ABI-009
Prospective phase 2, open-label, multi-institutional basket trial to determine the efficacy and safety of nab-sirolimus administered by IV infusion to patients
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Pathogenic inactivating TSC1 alterations | Experimental | Patients with pathogenic inactivating TSC1 alterations. Receives: Drug: nab-sirolimus |
| Arm B: Pathogenic inactivating TSC2 alterations | Experimental | Patients with pathogenic inactivating TSC2 alterations. Receives: Drug: nab-sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
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.
Measured: 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.
Secondary outcomes (7)
Duration of Response (DOR)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: From first dose of study treatment to the date of disease progression or death
Overall Survival
Number of months from study treatment initiation to the date of death due to any cause
Measured: From first dose of study treatment to the date of death
Patient-Reported Outcome
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.
Measured: D1 of every cycle up to Cycle 24
Incidence and Severity of Treatment-emergent and Treatment-related Adverse Events (AEs)
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start10 Mar 2022
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aadi Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103358
- Sponsor's protocol ID
- TSC-007
- Status last verified
- Sep 2026
- First submitted
- 22 Oct 2021
- Last updated
- 28 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No