ClinicalTrials.gg
CompletedNCT05997056Updated Aug 25, 2026Results posted

Trial of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the Gastrointestinal Tract, Lung, or Pancreas Who Have Not Received Prior Treatment With mTOR Inhibitors

A Phase 2 interventional study of nab-sirolimus in Neuroendocrine Tumors, NET and Pancreatic Neuroendocrine Tumor, sponsored by Aadi Bioscience, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Aadi Bioscience, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

A Phase 2 multi-center, open-label, single arm study of nab-sirolimus in patients with well-differentiated neuroendocrine tumors (NETs) of the gastrointestinal tract, lung, or pancreas who have not received prior treatment with mTOR inhibitors

Read the detailed description

This is a prospective phase 2 single arm, open-label, multi-institutional study to determine the efficacy and safety prospective of nab-sirolimus and patients with functional or non-functional, well-differentiated, locally advanced unresectable in metastatic NETs of the GI tract, lung, or pancreas.

02

Conditions studied

  • Neuroendocrine Tumors
  • NET
  • Pancreatic Neuroendocrine Tumor
  • Gastrointestinal Neuroendocrine Tumor
  • Pulmonary Neuroendocrine Tumor

Keywords

  • FYARRO
  • nab-sirolimus
  • ABI-009
  • Neuroendocrine Tumors
  • NET
  • Pancreatic Neuroendocrine Tumor
  • Gastrointestinal Neuroendocrine Tumor
  • Pulmonary Neuroendocrine Tumor
03

In context

Neuroendocrine Tumors

542 studies on the registry are indexed under Neuroendocrine Tumors; 135 are open to participants now.

This study's enrollment of 12 is below the median of 41 across 387 interventional studies indexed under Neuroendocrine Tumors.

Browse Neuroendocrine Tumors studies →

Lead sponsor

Aadi Bioscience, Inc. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with functional or non-functional, well-differentiated, locally advanced unresectable or NETs of the GI tract, lung, or pancreas who have received 2 or less excluding somatostatin analogs
  2. Patients with functional NETs may enroll if:

    1. the patient has been on a stable dose of an somatostatin analogs for ≥12 weeks and
    2. the patient has experienced disease progression while on stable somatostatin analogs dose
  3. Patients must have 1 or more measurable target lesions by v1.1
  4. Age: 18 years or older
  5. (ECOG) performance status 0 or 1 or Performance Status (KPS) ≥80
  6. Adequate liver function:

    1. Total ≤1.5 × (ULN) (unless due to Gilbert's syndrome or attributable to liver metastases, then ≤3 × ULN)
    2. (AST) and alanine transaminase (ALT) ≤2.5 × ULN (≤5 × ULN if attributable to liver metastases)
  7. Adequate renal function: ≥30 mL/min, Cockcroft-Gault creatinine clearance = ((140-age) × weight[kg]) / (72 × serum creatinine [mL/min]) × 0.85, if female.
  8. Adequate hematologic parameters:

    1. (ANC) ≥1.0 × 10\^9/L (growth factor support allowed)
    2. count ≥100,000/mm\^3 (100 × 10\^9/L) (transfusion and/or growth factor support allowed)
    3. ≥8.0 g/dL (transfusion and/or growth factor support allowed)
  9. Fasting serum triglyceride must be ≤300 mg/dL; fasting serum cholesterol must be less than or equal to 350 mg/dL
  10. Minimum of 4 weeks since any major surgery, completion of radiation, and adequately recovered from the acute toxicities of any prior therapy, including neuropathy, to Grade ≤1
  11. Male or non-pregnant and non-breastfeeding female:

    1. Females of must agree to use effective or abstinence without interruption from 28 days prior to starting study medication throughout 3 months after last dose of study medication 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 EOS 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 study medication. A second form of birth control is required even if he has undergone a successful vasectomy.
    3. Sexual abstinence is considered a highly effective contraceptive method only if defined as refraining from heterosexual intercourse from 28 days prior to starting study medication throughout 3 months after last dose of study medication. The reliability of sexual abstinence should be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient.
  12. The patient or the patient's legal guardian(s) understand(s) and sign(s) the
  13. Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures
  14. Patients with a known history of (HIV) infection are eligible if:

    1. There has been no acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection in 12 months prior to enrollment.
    2. The patient has been receiving an antiretroviral therapy regimen for ≥4 weeks and the HIV viral load is \<400 copies/mL prior to enrollment.
    3. Antiretroviral therapy regimen does not include strong cytochrome (CYP)3A4 inhibitors or inducers

Exclusion criteria

Exclusion Criteria:

  1. Prior treatment with mTOR inhibitors including nab-sirolimus

    Note: Patients who have previously received locoregional or liver-directed therapies (radiofrequency or microwave ablation, transarterial chemoembolization, etc.) are eligible to enroll in the study.

  2. Patients with functional NETs who are experiencing uncontrolled symptoms attributed to hormones and other vasoactive substances secreted by the tumor
  3. Patients with inactivating TSC1 or TSC2 alterations (based on tissue or liquid NGS)
  4. Severe (Grade ≥3) ongoing infection requiring parenteral or oral anti-infective treatment, either ongoing or completed ≤7 days prior to enrollment
  5. Patients who have any severe and/or uncontrolled medical or psychiatric conditions or other conditions that could affect their participation including:

    1. Known or suspected
    2. Severe heart disease defined as unstable angina pectoris, Class III or IV congestive heart failure, myocardial infarction ≤6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia or any other cardiac disease.
    3. Severe lung disease defined as a diffusing capacity for carbon monoxide that is ≤50% of normal predicted value and/or an O2 saturation ≤88% at rest on room air

      (Note: Spirometry and pulmonary function tests are 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 other than the one under treatment unless the patient is disease-free for more than 5 years from diagnosis. Controlled non-melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer, certain low-grade hematologic malignancies (eg, chronic lymphocytic leukemia, 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 mmHg and/or diastolic blood pressure ≥100 mmHg)
    7. Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension
    8. Active and/or infection and detectable viral load despite antiviral therapy.
  6. Required use of concomitant medications with strong interactions (induction or inhibition) should be discontinued (strong inhibitors include ketoconazole, itraconazole, voriconazole, erythromycin, clarithromycin, telithromycin; strong inducers include rifampin and rifabutin). These agents must be discontinued prior to first dose of nab-sirolimus.
Terms in these criteria, in plain language(23)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    neuroendocrine tumors

    Patients with well-differentiated neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas.

    Drug: nab-sirolimus

Interventions

  • Prospective phase 2 single arm, open-label, multi-institutional study to determine the efficacy and safety prospective of nab-sirolimus administered by IV infusion

    Also known as: ABI-009

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Objective Response Rate

    Objective Response Rate (ORR) is defined as the proportion of patients with best overall response (BOR) of confirmed partial response (PR) or complete response (CR) from the time of study treatment initiation until progression of disease (PD) as determined by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression (PD) is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or the appearance of one or more new lesions.

    Time frame: From the start of study treatment to radiographically confirmed disease progression (PD) per RECIST v1.1, assessed at screening, every 6 weeks (±7 days) for the first 12 weeks, and every 12 weeks (±7 days) thereafter, up to 22 months.

Secondary outcomes

  1. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events.

    The percentage of participants experiencing at least one treatment-emergent adverse event (TEAE) and treatment-related adverse event. Adverse events are defined as treatment-emergent (TEAEs) if they began or worsened on or after the first administration of study drug through 28 days after the last administration. Severity of adverse events is graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Time frame: From first dose of study treatment through end of treatment (estimated up to 18 months) plus safety follow-up of 30 days after the last dose.

  2. Duration of Response (DOR)

    Duration of Response (DOR) is determined for patients with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR), defined as the time from the scan first showing response by RECIST v1.1 to disease progression (PD) or death from any cause. Progression (PD) is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or the appearance of one or more new lesions.

    Time frame: From first documented response (CR or PR) to radiographically confirmed disease progression (PD) per RECIST v1.1 or death from any cause, assessed at screening, every 6 weeks for the first 12 weeks, and every 12 weeks thereafter, up to 22 months

  3. Disease Control Rate (DCR)

    Disease Control Rate (DCR) is defined as the proportion of patients achieving a best overall response (BOR) of confirmed complete response (CR), partial response (PR) (either of any duration), or stable disease (SD) lasting \>=12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 following study treatment initiation. Progression (PD) is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or the appearance of one or more new lesions.

    Time frame: From the start of study treatment to radiographically confirmed disease progression (PD) per RECIST v1.1, assessed at screening, every 6 weeks for the first 12 weeks, and every 12 weeks thereafter, up to 22 months

  4. Time to Response (TTR)

    Time to Response (TTR) is defined as the time from the first dose of study medication to the initial measurement of complete response (CR) or partial response (PR), where CR or PR is subsequently confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression (PD) is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or the appearance of one or more new lesions.

    Time frame: From the first dose of study treatment to the initial documentation of complete response (CR) or partial response (PR) per RECIST v1.1 , assessed at screening, every 6 weeks for the first 12 weeks, and every 12 weeks thereafter, up to 22 months

  5. Progression-free Survival(PFS)

    Number of months from study treatment initiation to the date of disease progression or death due to any cause

    Time frame: From first dose of study treatment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed every 6 weeks for the first 12 weeks and every 12 weeks thereafter, up to approximately 21 months

  6. Overall Survival(OS)

    Number of months from study treatment initiation to the date of death due to any cause

    Time frame: From first dose of study treatment until the date of death from any cause, assessed approximately every 12 weeks following the end-of-treatment visit, up to approximately 24 months.

07

Results

Posted Aug 25, 2026

Participant flow

Participants were enrolled from four sites in the United States.

Participant flow — Overall Study
MilestoneNeuroendocrine Tumors
Started12
Completed1
Not completed11
Withdrew: Withdrawal by subject1
Withdrew: Death2
Withdrew: Study terminated by sponsor8

Outcome measures

PrimaryPercentage of Participants With Objective Response Rate

Objective Response Rate (ORR) is defined as the proportion of patients with best overall response (BOR) of confirmed partial response (PR) or complete response (CR) from the time of study treatment initiation until progression of disease (PD) as determined by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression (PD) is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or the appearance of one or more new lesions.

Time frame:
From the start of study treatment to radiographically confirmed disease progression (PD) per RECIST v1.1, assessed at screening, every 6 weeks (±7 days) for the first 12 weeks, and every 12 weeks (±7 days) thereafter, up to 22 months.
Reported as:
Number · Percent of participants
Percentage of Participants With Objective Response Rate
Percent of participantsNeuroendocrine Tumors
Percentage of Participants With Objective Response Rate8.3 (0.2 to 38.5)
SecondaryPercentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events.

The percentage of participants experiencing at least one treatment-emergent adverse event (TEAE) and treatment-related adverse event. Adverse events are defined as treatment-emergent (TEAEs) if they began or worsened on or after the first administration of study drug through 28 days after the last administration. Severity of adverse events is graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Time frame:
From first dose of study treatment through end of treatment (estimated up to 18 months) plus safety follow-up of 30 days after the last dose.
Reported as:
Number · Percent of participants
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events.
Percent of participantsNeuroendocrine Tumors
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events.100
SecondaryDuration of Response (DOR)

Duration of Response (DOR) is determined for patients with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR), defined as the time from the scan first showing response by RECIST v1.1 to disease progression (PD) or death from any cause. Progression (PD) is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or the appearance of one or more new lesions.

Time frame:
From first documented response (CR or PR) to radiographically confirmed disease progression (PD) per RECIST v1.1 or death from any cause, assessed at screening, every 6 weeks for the first 12 weeks, and every 12 weeks thereafter, up to 22 months
Reported as:
Median · Months
Duration of Response (DOR)
MonthsNeuroendocrine Tumors
Duration of Response (DOR)NA (NA to NA)
SecondaryDisease Control Rate (DCR)

Disease Control Rate (DCR) is defined as the proportion of patients achieving a best overall response (BOR) of confirmed complete response (CR), partial response (PR) (either of any duration), or stable disease (SD) lasting \>=12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 following study treatment initiation. Progression (PD) is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or the appearance of one or more new lesions.

Time frame:
From the start of study treatment to radiographically confirmed disease progression (PD) per RECIST v1.1, assessed at screening, every 6 weeks for the first 12 weeks, and every 12 weeks thereafter, up to 22 months
Reported as:
Number · Percent of participants
Disease Control Rate (DCR)
Percent of participantsNeuroendocrine Tumors
Disease Control Rate (DCR)50.0 (21.1 to 78.9)
SecondaryTime to Response (TTR)

Time to Response (TTR) is defined as the time from the first dose of study medication to the initial measurement of complete response (CR) or partial response (PR), where CR or PR is subsequently confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression (PD) is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or the appearance of one or more new lesions.

Time frame:
From the first dose of study treatment to the initial documentation of complete response (CR) or partial response (PR) per RECIST v1.1 , assessed at screening, every 6 weeks for the first 12 weeks, and every 12 weeks thereafter, up to 22 months
Reported as:
Median · Months
Time to Response (TTR)
MonthsNeuroendocrine Tumors
Time to Response (TTR)1.51 (NA to NA)
SecondaryProgression-free Survival(PFS)

Number of months from study treatment initiation to the date of disease progression or death due to any cause

Time frame:
From first dose of study treatment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed every 6 weeks for the first 12 weeks and every 12 weeks thereafter, up to approximately 21 months
Reported as:
Median · Months
Progression-free Survival(PFS)
MonthsNeuroendocrine Tumors
Progression-free Survival(PFS)10.0 (5.4 to NA)
SecondaryOverall Survival(OS)

Number of months from study treatment initiation to the date of death due to any cause

Time frame:
From first dose of study treatment until the date of death from any cause, assessed approximately every 12 weeks following the end-of-treatment visit, up to approximately 24 months.
Reported as:
Median · Months
Overall Survival(OS)
MonthsNeuroendocrine Tumors
Overall Survival(OS)NA (9.7 to NA)

Adverse events

Collected over From the first dose of study treatment until death from any cause, assessed continuously during the treatment period (and up to 28 days after the last dose) and approximately every 12 weeks during the survival follow-up period, up to approximately 22 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Neuroendocrine Tumors2/12 (16.7%)4/12 (33.3%)12/12 (100%)
Most frequent serious events
Most frequent serious events
EventNeuroendocrine Tumors
Coronavirus infectionInfections and infestations1/12
PneumoniaInfections and infestations1/12
Urinary tract infectionInfections and infestations1/12
VomitingGastrointestinal disorders1/12
Acute kidney injuryRenal and urinary disorders1/12
PneumonitisRespiratory, thoracic and mediastinal disorders1/12
Most frequent other events
Showing 10 of 110
Most frequent other events
EventNeuroendocrine Tumors
StomatitisGastrointestinal disorders9/12
FatigueGeneral disorders8/12
DiarrhoeaGastrointestinal disorders6/12
PruritusSkin and subcutaneous tissue disorders6/12
VomitingGastrointestinal disorders5/12
ConstipationGastrointestinal disorders4/12
Dry skinSkin and subcutaneous tissue disorders4/12
DysgeusiaNervous system disorders4/12
Abdominal painGastrointestinal disorders3/12
Dry mouthGastrointestinal disorders3/12

Baseline characteristics

Age, Customized
Age, Customized(Participants)Neuroendocrine Tumors
Age — <65 years4
Age — 65-74 years5
Age — > = 75 years3
Sex: Female, Male
Sex: Female, Male(Participants)Neuroendocrine Tumors
Female7
Male5
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Neuroendocrine Tumors
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American0
White10
More than one race0
Unknown or Not Reported1
08

Study locations

4 sites
  • Hoag Memorial Hospital Presbyterian
    Newport Beach, California 92663, United States
  • Rocky Mountain Cancer Centers
    Denver, Colorado 80218, United States
  • Texas Oncology
    Dallas, Texas 75246, United States
  • Medical College of Wisconsin Cancer Center
    Milwaukee, Wisconsin 53226, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05997056
Lead sponsor
Aadi Bioscience, Inc.
Responsible party
Sponsor
First posted
Aug 18, 2023
Start date
Oct 20, 2023
Primary completion
Oct 3, 2025
Completion
Oct 3, 2025
Results posted
Aug 25, 2026
Last update
Aug 25, 2026

Study contacts

Leonor Nazareno
study director · Aadi Bioscience

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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