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OncoMatch/Clinical Trials/NCT05997017

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

Is NCT05997017 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies nab-sirolimus for endometrial cancer.

Phase 2RecruitingAadi Bioscience, Inc.NCT05997017Data as of Jun 2026

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

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Extracted eligibility criteria

Treatments studied

Other

nab-sirolimus

Cancer type

Endometrial Cancer

Biomarker criteria

Excluded: TSC1 inactivating alteration

Excluded: TSC2 inactivating alteration

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 1 prior line
Min 0 prior lines

Cannot have received: mtor inhibitor (nab-sirolimus)

Lab requirements

Blood counts

ANC ≥1.0 × 10^9/L (growth factor support allowed); Platelet count ≥100,000/mm3 (transfusion and/or growth factor support allowed); Hemoglobin ≥8.0 g/dL (transfusion and/or growth factor support allowed)

Kidney function

creatinine clearance (CrCL) ≥30 mL/min based on Cockcroft-Gault

Liver function

Total bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome, then ≤3 × ULN); AST ≤2.5 × ULN (≤5 × ULN if attributable to liver metastases)

Adequate liver function: Total bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome, then ≤3 × ULN); 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: ANC ≥1.0 × 10^9/L (growth factor support allowed); Platelet count ≥100,000/mm3 (transfusion and/or growth factor support allowed); Hemoglobin ≥8.0 g/dL (transfusion and/or growth factor support allowed).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Michael Birrer, MD, PhD · Little Rock, Arkansas
  • Mount Sinai Comprehensive Cancer Center · Miami Beach, Florida
  • Women's Cancer Center of Nevada · Las Vegas, Nevada
  • Memorial Sloan Kettering Cancer Center · New York, New York
  • Levine Cancer Institute · Charlotte, North Carolina

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT05997017 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior mtor inhibitor disqualifies patients from enrollment.

Are patients with TSC1 alterations eligible?

No. TSC1 inactivating alteration is an exclusion criterion.

Are patients with TSC2 alterations eligible?

No. TSC2 inactivating alteration is an exclusion criterion.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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