A Phase 2 Multi-center Open-label Trial of nab-Sirolimus in Combination with Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer
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.
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.
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.
Single group
nab-sirolimus
DrugProspective Phase 2, open-label, multi-institutional study to evaluate the efficacy and safety of nab-sirolimus + letrozole in patients
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.
Duration of response (DOR)
Determined for patients with BOR of confirmed CR or PR
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)
Time to response (TTR)
Time from study treatment initiation to initial measurement of CR or PR, where CR or PR is subsequently confirmed
Progression-free survival (PFS)
Number of months from study treatment initiation to the date of disease progression 3 or death due to any cause
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