Study on Nab-Sirolimus and Letrozole for Advanced or Returning Endometrioid Endometrial Cancer
Sponsor: Aadi Bioscience, Inc.
ClinicalTrials ID:NCT05997017
This clinical trial is testing a combination of two drugs, nab-Sirolimus and Letrozole, to see if they are safe and effective in treating patients with advanced or returning endometrioid endometrial cancer who have had little or no prior chemotherapy.
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Program Overview
This study is a Phase 2 trial conducted at multiple centers to evaluate the effectiveness and safety of combining nab-Sirolimus and Letrozole in patients with advanced or recurrent endometrioid endometrial cancer. Participants will receive nab-Sirolimus through an IV on specific days of a 21-day cycle, along with daily oral Letrozole, until the treatment is no longer beneficial or causes unacceptable side effects.
Description
This clinical trial is designed to test the combination of nab-Sirolimus and Letrozole in patients with advanced or recurrent endometrioid endometrial cancer. The study aims to determine if this combination is effective and safe for patients who have had 0-1 prior chemotherapy treatments for their cancer. Participants will receive nab-Sirolimus intravenously on Days 1 and 8 of a 21-day cycle, and take Letrozole orally every day. Treatment will continue until it is no longer effective, causes unacceptable side effects, or the patient decides to stop. The study will monitor the patients' response to the treatment and any side effects they experience.
Eligibility Criteria
Inclusion Criteria
- Must have advanced or recurrent endometrioid endometrial cancer confirmed by a doctor.
- Must have at least one measurable tumor as seen on a CT or MRI scan.
- Cancer must be advanced or spread to other areas where surgery is not an option.
- Can have had previous treatments, but must meet specific conditions:
- Previous chemotherapy or other treatments must have ended at least 6 months ago.
- Can have had 0-1 prior chemotherapy treatments for advanced cancer, completed at least 3 months ago.
- Non-chemotherapy treatments must have ended at least 4 weeks ago.
- Must have responded to at least one previous treatment.
- Must be 18 years or older.
- Must have a good performance status (ECOG 0 or 1).
- Must have adequate liver and kidney function based on specific blood tests.
- Must have adequate blood cell counts.
- Must have controlled cholesterol and triglyceride levels.
- Must not be pregnant or breastfeeding and agree to use effective birth control.
- Must understand and agree to the study requirements and sign informed consent.
- Must be willing to comply with study visits and procedures.
- Patients with HIV are eligible if they meet specific conditions regarding their health and treatment.
Exclusion Criteria
- Previous treatment with mTOR inhibitors like nab-Sirolimus.
- Known genetic alterations in TSC1 or TSC2 unless a specific study is closed.
- Severe ongoing infections requiring treatment.
- Cancer that has never responded to previous treatments.
- Known or suspected brain metastases.
- Severe heart or lung disease.
- Uncontrolled medical conditions that could be worsened by the study treatment.
- History of other cancers unless disease-free for over 5 years, with some exceptions.
- Uncontrolled high blood pressure.
- History of lung diseases like interstitial lung disease or pneumonitis.
- Active hepatitis B or C infections.
- Use of medications that strongly interact with the study drugs.
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