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Endometrial CancerPhase 2NCT05997017

Trial of Nab-Sirolimus in Combination With Letrozole in Patients With Advanced or Recurrent Endometrioid Endometrial Cancer

A Phase 2 study testing nab-sirolimus in people with Endometrial Cancer and Endometrioid Tumor, run by Aadi Bioscience, Inc. at 9 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

A Phase 2 Multi-center Open-label Trial of nab-Sirolimus in Combination with Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Endometrial Cancer, Endometrioid Tumor, Cancer
What is being tested?
nab-sirolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
9 sitesUnited States
Study dates
28 Dec 2023to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 must have clinically confirmed advanced or recurrent endometrioid endometrial carcinoma. Histologic documentation of the recurrence is suggested but not required.
  • All patients must have 1 or more measurable target lesion at baseline by computed tomography (CT; or magnetic resonance imaging [MRI] if CT scans are contraindicated) as defined by RECIST version 1.1.
  • Patients must have EEC that is metastatic or locally advanced where surgical resection is not an option or likely to result in severe morbidity.
  • Prior treatment history:
  • Adjuvant setting - treatment with chemotherapy, hormonal therapy,checkpoint inhibitors, and/or other therapy is permitted as long as theadjuvant therapy ended ≥6 months from enrollment.
  • Recurrent/advanced/metastatic setting - treatment with 0-1 prior chemotherapy regimens is permitted (patients may be naïve to chemotherapy); chemotherapy must have been completed ≥3 months prior to enrollment. Patients are permitted to have received adjuvant chemotherapy and no more than 1 line of chemotherapy in the recurrent/advanced/metastatic setting.
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  • Non-chemotherapy-based treatment (eg, checkpoint inhibitors, hormonal therapy, and/or small molecule agents) is permitted at any point as long as therapy ended ≥4 weeks prior to enrollment.
  • Patients who have received prior therapy in the recurrent/advanced/metastatic setting must have achieved a complete or partial response(investigator-assessed) to at least 1 therapy.
  • Age: 18 years or older.
  • Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • 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 (CrCL) ≥30 mL/min based on Cockcroft-Gault
  • 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 less than or equal to 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.
  • 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 nab-Sirolimus through 3 months after the last dose of nab-Sirolimus 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.
  • 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 understands and signs 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 an mTOR inhibitor, including nab-sirolimus.
  • Patients with known inactivating TSC1 or TSC2 alterations (based on tissue or liquid next generation sequencing [NGS]) unless the PRECISION 1 study (NCT05103358) has been closed to enrollment.
  • Severe (Grade ≥3) ongoing infection requiring parenteral or oral anti-infective treatment, either ongoing or completed ≤7 days prior to enrollment.
  • Patients with primary refractory disease (ie, those who have never achieved a complete or partial response to prior therapy) are not permitted on study.
  • Patients with the following are excluded:
  • Known or suspected brain metastases.
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  • Severe heart disease defined as unstable angina pectoris, New York Heart Association (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 (DLCO) that is ≤50% of normal predicted value and/or an O2 saturation ≤88% at rest on room air (Note: spirometry and pulmonary function tests [PFTs] 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 completion of therapy administered with curative intent. Controlled non-melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer, certain low grade hematologic malignancies (eg, chronic lymphocytic leukemia [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 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

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aadi Bioscience Medical Information contact

1-888-246-2234

MedInfo@aadibio.com

9 sites in 1 country

United States9 sites, 9 recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

    Leah J Wilson, BS, RN, OCN, 980-442-2333, leah.j.wilson@atriumhealth.org

    Allison M Puechi, MD

    Recruiting

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89106

    Thania Escamilla, 702-693-6870, tescamilla@wccenter.com

    Jacky Amador, 702-693-6870, jamador@wccenter.com

    Recruiting

  • Michael Birrer, MD, PhD

    Little Rock, Arkansas, 72205

    Aaron Holley, jaholley@uams.edu

    Matthew Kovak, mrkovak@uams.edu

    Recruiting

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

    Michelle McClosky, 305-674-2625, Michelle.Mcclosky@msmc.com

    Brian Slomovitz, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Angela Green, MD, 646-888-4224, greena@mskcc.org

    Angela Green, MD

    Recruiting

  • Oklahoma University Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

    Christine Pappaterra, 405-271-8777, Christine-pappaterra@ouhsc.edu

    Lauren Dockery, MD

    Recruiting

  • Women & Infants Hospital

    Providence, Rhode Island, 02905

    Pamela Smith, 401-274-1122 ext. 48181, oncologyresearch@wihri.org

    Cara Mathews, MD

    Recruiting

  • Swedish Cancer Institute

    Seattle, Washington, 98104

    Anh Lam, 206-386-2227, Anh.lam@swedish.org

    Fernanda Musa, MD

    Recruiting

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

    Shelly Maxfield, CCRP, 903-579-9840, shelly.maxfield@usoncology.com

    Anna Priebe, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2 Multi-center Open-label Trial of Nab-Sirolimus in Combination With Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer

A Phase 2 Multi-center Open-label Trial of nab-Sirolimus in Combination with Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer

Read the detailed description

This is a prospective phase 2, open-label, multi-institutional study to evaluate the efficacy and safety of nab-sirolimus + letrozole in patients with advanced or recurrent endometrioid endometrial carcinoma who have received 0-1 prior lines of chemotherapy in the recurrent/metastatic setting. Patients will be treated with nab-sirolimus (given IV on Days 1 and 8 in a 21-day cycle, combined with letrozole (orally, daily) until unacceptable toxicity or disease progression, or until in the opinion of the Investigator the patient is no longer benefiting from therapy, or at patient discretion.

Being tested
nab-sirolimus
Keywords
nab-Sirolimus, FYARRO, Letrozole, Endometrial, Recurrent, ABI-009, Endometrial Carcinoma, Endometrioid Tumor, Endometrial Cancer, Recurrent Endometrial Carcinoma, Endometrioid Endometrial Cancer
Medical subject headings
Endometrial Neoplasms, Neoplasms, Recurrence

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 study to evaluate the efficacy and safety of nab-sirolimus + letrozole in patients

Study groups in NCT05997017
Study groupRoleWhat they receive
Endometrioid Endometrial CancerExperimentalPatients with advanced or recurrent endometrioid endometrial carcinoma
Receives: Drug: nab-sirolimus

What is being measured

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

  1. Overall response rate (ORR)

    ORR, 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 RECIST v1.1.

    Measured: 12 Months

Secondary outcomes (6)

  1. Duration of response (DOR)

    Determined for patients with BOR of confirmed CR or PR

    Measured: 12 Months

  2. Disease Control Rate (DCR): CR or PR

    BOR of confirmed CR or PR (either of any duration) or stable disease (SD) following study treatment initiation (by IRR)

    Measured: 12 Months

  3. Time to response (TTR)

    Time from study treatment initiation to initial measurement of CR or PR, where CR or PR is subsequently confirmed

    Measured: 12 Months

  4. Progression-free survival (PFS)

    Number of months from study treatment initiation to the date of disease progression 3 or death due to any cause

    Measured: 12 Months

  5. Overall survival (OS)

    Number of months from study treatment initiation to the date of death due to any cause or last follow up date if alive

    Measured: 24 Months

  6. Incidence and severity

    Of treatment-emergent and treatment-related adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

    Measured: 12 Months

Timeline

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

  1. First posted18 Aug 2023
  2. Study start28 Dec 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05997017
Sponsor's protocol ID
EEC-201
Status last verified
Nov 2025
First submitted
10 Aug 2023
Last updated
13 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nab-sirolimus in people with Endometrial Cancer and Endometrioid Tumor, run by Aadi Bioscience, Inc. at 9 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 29 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aadi Bioscience Medical Information (1-888-246-2234, MedInfo@aadibio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: 12 Months). 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 NCT05997017.

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 13 Nov 2025.

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