NCT05997017

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
13mo left

Started Dec 2023

Typical duration for phase_2

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Dec 2023Jun 2027

First Submitted

Initial submission to the registry

August 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

December 28, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

November 13, 2025

Status Verified

November 1, 2025

Enrollment Period

2.9 years

First QC Date

August 10, 2023

Last Update Submit

November 12, 2025

Conditions

Endometrial CancerEndometrioid TumorCancerTumorRecurrent Endometrial CarcinomaEndometrioid Endometrial Cancer

Keywords

nab-SirolimusFYARROLetrozoleEndometrialRecurrentABI-009Endometrial CarcinomaEndometrioid TumorEndometrial CancerRecurrent Endometrial CarcinomaEndometrioid Endometrial Cancer

Outcome Measures

Primary Outcomes (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.

    12 Months

Secondary Outcomes (6)

  • Duration of response (DOR)

    12 Months

  • Disease Control Rate (DCR): CR or PR

    12 Months

  • Time to response (TTR)

    12 Months

  • Progression-free survival (PFS)

    12 Months

  • Overall survival (OS)

    24 Months

  • +1 more secondary outcomes

Study Arms (1)

Endometrioid Endometrial Cancer

EXPERIMENTAL

Patients with advanced or recurrent endometrioid endometrial carcinoma

Drug: nab-sirolimus

Interventions

nab-sirolimusDRUG

Prospective Phase 2, open-label, multi-institutional study to evaluate the efficacy and safety of nab-sirolimus + letrozole in patients

Also known as: ABI-009
Endometrioid Endometrial Cancer

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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:
  • +14 more criteria

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Michael Birrer, MD, PhD

Little Rock, Arkansas, 72205, United States

RECRUITING

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

RECRUITING

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89106, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Oklahoma University Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

RECRUITING

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

RECRUITING

Swedish Cancer Institute

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Endometrial NeoplasmsNeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Willis Navarro, MD

    Aadi Bioscience

    STUDY DIRECTOR

Central Study Contacts

Aadi Bioscience Medical Information

CONTACT

1-888-246-2234MedInfo@aadibio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 18, 2023

Study Start

December 28, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

November 13, 2025

Record last verified: 2025-11

Locations

US(9)