Actively Recruiting
Trial of Nab-Sirolimus in Combination With Letrozole in Patients With Advanced or Recurrent Endometrioid Endometrial Cancer
Led by Aadi Bioscience, Inc. · Updated on 2025-11-13
29
Participants Needed
9
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 2 Multi-center Open-label Trial of nab-Sirolimus in Combination with Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer
CONDITIONS
Official Title
Trial of Nab-Sirolimus in Combination With Letrozole in Patients With Advanced or Recurrent Endometrioid Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have clinically confirmed advanced or recurrent endometrioid endometrial carcinoma
- At least one measurable target lesion at baseline by CT or MRI
- Cancer must be metastatic or locally advanced where surgery is not an option or may cause severe harm
- Prior chemotherapy: 0-1 lines allowed in recurrent/metastatic setting; completed at least 3 months prior
- Non-chemotherapy treatments allowed if ended at least 4 weeks before enrollment
- Prior therapy in recurrent/metastatic setting must have achieved complete or partial response
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate liver function with bilirubin and AST within specified limits
- Adequate kidney function with creatinine clearance ≥30 mL/min
- Adequate blood counts with specified minimum neutrophils, platelets, and hemoglobin
- Fasting triglycerides ≤300 mg/dL and cholesterol ≤350 mg/dL
- At least 4 weeks since major surgery, radiation, or prior systemic therapy with recovery
- Non-pregnant and non-breastfeeding females must use effective contraception and have negative pregnancy tests
- Signed informed consent and ability to comply with study procedures
- Patients with HIV eligible if no AIDS-defining infection in past 12 months, on antiretroviral therapy for ≥4 weeks, viral load <400 copies/mL, and no strong CYP3A4 inhibitors or inducers in regimen
You will not qualify if you...
- Prior treatment with any mTOR inhibitor, including nab-sirolimus
- Known inactivating TSC1 or TSC2 genetic alterations unless related study is closed
- Severe ongoing infection requiring treatment or completed less than 7 days before enrollment
- Primary refractory disease with no prior response to therapy
- Known or suspected brain metastases
- Severe heart disease such as unstable angina, severe heart failure, recent myocardial infarction, or serious arrhythmias
- Severe lung disease with low lung function or oxygen saturation
- Uncontrolled nonmalignant medical illnesses that may be worsened by study therapy
- History of other cancers unless disease-free for more than 5 years or certain controlled cancers
- Uncontrolled high blood pressure
- History of interstitial lung disease, pneumonitis, or pulmonary hypertension
- Active hepatitis B or C infection with detectable viral load despite treatment
- Use of medications with strong CYP3A4 interactions that cannot be discontinued before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Michael Birrer, MD, PhD
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
3
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89106
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
5
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
6
Oklahoma University Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
7
Women & Infants Hospital
Providence, Rhode Island, United States, 02905
Actively Recruiting
8
Texas Oncology - Tyler
Tyler, Texas, United States, 75702
Actively Recruiting
9
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
A
Aadi Bioscience Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here