Neuroendocrine TumorsPhase 2NCT05997056
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 study testing nab-sirolimus in people with Neuroendocrine Tumors and NET, run by Aadi Bioscience, Inc. at 4 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, NET, Pancreatic Neuroendocrine Tumor
- 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
- 12 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Oct 2023to 3 Oct 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with functional or non-functional, well-differentiated, locally advanced unresectable or metastatic NETs of the GI tract, lung, or pancreas who have received 2 or less prior lines of therapy excluding somatostatin analogs
- Patients with functional NETs may enroll if:
- the patient has been on a stable dose of an somatostatin analogs for ≥12 weeks and
- the patient has experienced disease progression while on stable somatostatin analogs dose
- Patients must have 1 or more measurable target lesions by RECIST v1.1
- Age: 18 years or older
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- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or Karnofsky Performance Status (KPS) ≥80
- Adequate liver function:
- Total bilirubin ≤1.5 × upper limit of normal (ULN) (unless due to Gilbert's syndrome or attributable to liver metastases, then ≤3 × ULN)
- Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2.5 × ULN (≤5 × ULN if attributable to liver metastases)
- Adequate renal function: creatinine clearance ≥30 mL/min, Cockcroft-Gault creatinine clearance = ((140-age) × weight[kg]) / (72 × serum creatinine [mL/min]) × 0.85, if female.
- Adequate hematologic parameters:
- Absolute neutrophil count (ANC) ≥1.0 × 10^9/L (growth factor support allowed)
- Platelet count ≥100,000/mm^3 (100 × 10^9/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 less than or equal to 350 mg/dL
- 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
- 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 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.
- 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.
- 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.
- The patient or the patient's 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
- Patients with a known history of human immunodeficiency virus (HIV) infection are eligible if:
- There has been no acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection in 12 months prior to enrollment.
- The patient has been receiving an antiretroviral therapy regimen for ≥4 weeks and the HIV viral load is <400 copies/mL prior to enrollment.
- Antiretroviral therapy regimen does not include strong cytochrome (CYP)3A4 inhibitors or inducers
Who cannot join
- 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.
- Patients with functional NETs who are experiencing uncontrolled symptoms attributed to hormones and other vasoactive substances secreted by the tumor
- Patients with inactivating TSC1 or TSC2 alterations (based on tissue or liquid NGS)
- Severe (Grade ≥3) ongoing infection requiring parenteral or oral anti-infective treatment, either ongoing or completed ≤7 days prior to enrollment
- Patients who have any severe and/or uncontrolled medical or psychiatric conditions or other conditions that could affect their participation including:
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- Known or suspected brain metastases
- Severe heart disease defined as unstable angina pectoris, NYHA Class III or IV congestive heart failure, myocardial infarction ≤6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease.
- 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.)
- 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. 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.
- Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg)
- Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension
- Active Hepatitis B and/or Hepatitis C infection and detectable viral load despite antiviral therapy.
- Required use of concomitant medications with strong CYP3A4 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Texas Oncology
Dallas, Texas, 75246
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
About this study
Official title: 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
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.
- Conditions
- Neuroendocrine Tumors, NET, Pancreatic Neuroendocrine Tumor, Gastrointestinal Neuroendocrine Tumor, Pulmonary Neuroendocrine Tumor
- Being tested
- nab-sirolimus
- Keywords
- FYARRO, nab-sirolimus, ABI-009, Neuroendocrine Tumors, NET, Pancreatic Neuroendocrine Tumor, Gastrointestinal Neuroendocrine Tumor, Pulmonary Neuroendocrine Tumor
- Medical subject headings
- Neuroendocrine Tumors, Adenoma, Islet Cell, Gastro-enteropancreatic neuroendocrine tumor
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 single arm, open-label, multi-institutional study to determine the efficacy and safety prospective of nab-sirolimus administered by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| neuroendocrine tumors | Experimental | Patients with well-differentiated neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas. Receives: Drug: nab-sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (6)
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.
Measured: 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.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Progression-free Survival（PFS）
Number of months from study treatment initiation to the date of disease progression or death due to any cause
Measured: 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
Overall Survival（OS）
Number of months from study treatment initiation to the date of death due to any cause
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start20 Oct 2023
- Primary completion3 Oct 2025
- Study completion3 Oct 2025
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 Neuroendocrine TumorsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aadi Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leonor Nazareno, Study director, Aadi Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997056
- Sponsor's protocol ID
- NET-202
- Status last verified
- Jul 2026
- First submitted
- 10 Aug 2023
- Last updated
- 25 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05997056
- Acronym / sponsor ID
- NET-202
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aadi Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 3 Oct 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 18 Aug 2023 (actual)
- Results
- Posted 25 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neuroendocrine tumors | Experimental | Drug: nab-sirolimusPatients with well-differentiated neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Patients with functional or non-functional, well-differentiated, locally advanced unresectable or metastatic NETs of the GI tract, lung, or pancreas who have received 2 or less prior lines of therapy excluding somatostatin analogs
- Patients with functional NETs may enroll if:
- Patients must have 1 or more measurable target lesions by RECIST v1.1
- Age: 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or Karnofsky Performance Status (KPS) ≥80
Key exclusion criteria (16 listed)
- 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.
- Patients with functional NETs who are experiencing uncontrolled symptoms attributed to hormones and other vasoactive substances secreted by the tumor
- Patients with inactivating TSC1 or TSC2 alterations (based on tissue or liquid NGS)
- Severe (Grade ≥3) ongoing infection requiring parenteral or oral anti-infective treatment, either ongoing or completed ≤7 days prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nab-sirolimusAlso: ABI-009Prospective phase 2 single arm, open-label, multi-institutional study to determine the efficacy and safety prospective of nab-sirolimus administered by IV infusion | Drug | neuroendocrine tumors |
Primary outcome
Percentage of Participants With Objective Response Rate
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.
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.
6 secondary outcomes
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events.
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.
Duration of Response (DOR)
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
Disease Control Rate (DCR)
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
Time to Response (TTR)
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
Progression-free Survival（PFS）
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
Overall Survival（OS）
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonor Nazareno study director
Aadi Bioscience
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nab-sirolimus in people with Neuroendocrine Tumors and NET, run by Aadi Bioscience, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Objective Response Rate (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.