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Tumor, SolidPhase 1NCT05661461

Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment

A Phase 1 study testing nab-sirolimus in people with Tumor, Solid and Tumor, run by Aadi Bioscience, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase 1, multi-center, open-label, dose-escalation study of nab-sirolimus in adult patients with locally advanced or metastatic solid tumors and moderate hepatic impairment or normal hepatic function. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tumor, Solid, Tumor, Advanced Solid Tumor
What is being tested?
nab-sirolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesUnited States
Study dates
23 Nov 2022to 2 Sep 2026
Phase
Phase 1
Are there results?
None posted in the registry

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

  • For All Patients
  • Willing and able to provide informed consent and comply with protocol requirements for the duration of the study.
  • Male or female patients at least 18 years of age at the time of signing the informed consent form.
  • Histologically confirmed locally advanced or metastatic solid tumors that is measurable or non-measurable.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
  • Adequate hematologic counts:
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  • Absolute neutrophil count (ANC) ≥1.0 × 109 /L (growth factor support allowed)
  • Platelet count ≥75,000/mm 3 (75 × 10 9 /L) (transfusion and/or growth factor support allowed)
  • Hemoglobin ≥8.0 g/dL (transfusion and/or growth factor support allowed)
  • Creatinine clearance ≥30 mL/min as assessed by the Cockcroft-Gault equation:
  • Creatinine Clearance ≥30 = (140 - age) × (weight[kg] / (72 x SCr[mL/min] x 0.85, if female
  • Fasting serum triglyceride must be ≤300 mg/dL; fasting serum cholesterol must be
  • ≤350 mg/dL.
  • Male or non-pregnant and non-breastfeeding female:
  • Females of child-bearing potential must agree to use highly effective contraception or abstinence without interruption from 28 days prior to first dose throughout 3 months after last dose and have a negative pregnancy test (urine or serum) result at screening 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 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. A second form of birth control is required even if he has undergone a successful vasectomy.
  • Minimum of 4 weeks since major surgery, completion of radiation, or completion of all prior systemic anticancer therapy, or at least 5 half-lives if the prior therapy is a single agent small-molecule therapeutic, and in either case adequately recovered from the acute toxicities of any prior therapy (including neuropathy) to Grade ≤1. For Patients with Normal Hepatic Function
  • Normal hepatic function (total bilirubin ≤ upper limit of normal [ULN] and aspartate aminotransferase [AST] ≤ULN). For Patients with Moderate Hepatic Impairment
  • Moderate hepatic impairment (total bilirubin 1.5-3.0 × ULN and any level of AST)

Who cannot join

  • Received prior treatment with an mTOR inhibitor within 4 weeks prior to first dose.
  • 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 magnetic resonance imaging (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.
  • 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. Note, controlled non melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer, or other adequately treated carcinoma-in-situ may be eligible, after documented discussion with the Medical Monitor.
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  • 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.
  • 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. Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients.
  • Have active severe (Grade ≥3) infection requiring intravenous (IV) antibiotics (contact medical monitor for clarification).
  • High-dose systemic corticosteroids (>10 mg of prednisone or its equivalent) are not permitted within 2 weeks of first dose. However, inhaled, intranasal, intra articular, and topical steroids are allowed.
  • Have a history of Gilbert's disease.
  • Any condition that in the opinion of the Investigator would place the patient at an unacceptable risk or cause the patient to be unlikely to fully participate or comply with study procedures.
  • For Patients with Moderate Hepatic Impairment
  • Had a clinical exacerbation of liver disease within the 2-week period prior to first dose (ie, abdominal pain, nausea, vomiting, anorexia, or fever).
  • Have clinically demonstrable, tense ascites.
  • Had evidence of acute viral hepatitis within 1 month prior to first dose.
  • Have evidence of hepatorenal syndrome.
  • Have a transjugular intrahepatic portosystemic shunt.
  • Have active stage 3 or 4 encephalopathy.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas, 78229

  • START Mountain Region

    West Valley City, Utah, 84119

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment

This is a phase 1, multi-center, open-label, dose-escalation study of nab-sirolimus in adult patients with locally advanced or metastatic solid tumors and moderate hepatic impairment or normal hepatic function.

Read the detailed description

This is a phase 1, multi-center, open-label, dose-escalation study of nab-sirolimus in adult patients with locally advanced or metastatic solid tumors and moderate hepatic impairment or normal hepatic function. Eligible patients will receive nab-sirolimus by intravenous (IV) infusion over 30 minutes (+10 min) on Days 1 and 8.

Being tested
nab-sirolimus
Medical subject headings
Neoplasms

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, nab-rapamycin, albumin-bound rapamycin

    This is a phase 1, multi-center, open-label, dose-escalation study of nab-sirolimus in adult patients with locally advanced or metastatic solid tumors and moderate hepatic impairment or normal hepatic function.

Study groups in NCT05661461
Study groupRoleWhat they receive
ExperimentalExperimentalnab-Sirolimus
Receives: Drug: nab-sirolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD for patients with moderate hepatic impairment

    Measured: Through Day 22

  2. Maximum concentration (Cmax)

    Measured: Time 0

  3. Area under the serum concentration-time curve

    Measured: Time 0 to time of the last quantifiable concentration (AUC 0-last)

  4. Area under the serum concentration-time curve

    Measured: Time 0 to 168 hours (AUC 0-168)

Secondary outcomes (10)

  1. Area under the serum concentration-time curve

    Measured: Time 0 extrapolated to infinity (AUC0-inf)

  2. Time to maximum observed serum concentration (T max)

    Measured: Time 0 to 168 hours (AUC 0-168)

  3. Clearance (CL)

    Measured: Time 0 to 168 hours (AUC 0-168)

  4. Total volume of distribution during the terminal phase (V z )

    Measured: Time 0 to 168 hours (AUC 0-168)

  5. Steady-state volume of distribution (V ss)

    Measured: Time 0 to 168 hours (AUC 0-168)

  6. Terminal elimination rate constant (λz )

    Measured: Time 0 to 168 hours (AUC 0-168)

  7. Terminal elimination half-life (t½ )

    Measured: Time 0 to 168 hours (AUC 0-168)

  8. Accumulation ratio based on Cmax

    Measured: Time 0 to 168 hours (AUC 0-168)

  9. Accumulation ratio based on AUC0-168

    Measured: Time 0 to 168 hours (AUC 0-168)

  10. Percent area under the serum concentration-time curve extrapolated (%AUCextrap )

    Measured: Time 0 to 168 hours (AUC 0-168)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2022
  2. Study start23 Nov 2022
  3. Primary completion19 Aug 2025
  4. Study completion2 Sep 2026

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05661461
Sponsor's protocol ID
HEP-001
Status last verified
Oct 2026
First submitted
14 Dec 2022
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing nab-sirolimus in people with Tumor, Solid and Tumor, run by Aadi Bioscience, Inc. at 2 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 19 inclusion and 21 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

MTD for patients with moderate hepatic impairment (time frame: Through Day 22). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05661461.

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 28 Oct 2026.

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