OncoMatch/Clinical Trials/NCT07209449
A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer
Is NCT07209449 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Abemaciclib and Elacestrant for endometrial cancer.
Treatment: Abemaciclib · Elacestrant — The researchers are doing this study to find out whether elacestrant is an effective and safe treatment alone or in combination with abemaciclib for people with advanced or recurrent ER+ endometrial cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Endocrine / hormonal
Cancer type
Endometrial Cancer
Biomarker criteria
Required: ESR1 overexpression (≥ 1% staining by IHC)
Patient must have ER-positive tumor status either from the most recent sample of advanced/recurrent disease or from an archival tissue. Documentation of ER-positive tumor with ≥ 1% staining by IHC as defined in the 2010 or 2020 American Society for Clinical Oncology recommendations for ER testing
Required: TP53 wild-type
p53 wt by IHC or TP53 wt by next generation sequencing platform
Excluded: MMR deficient
No known dMMR
Excluded: POLE mutation
No known POLE mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: platinum-based chemotherapy
Patients must have received previous platinum-based chemotherapy
Must have received: anti-PD-1 therapy
Patients must have received previous...treatment with a PD-1 inhibitor
Cannot have received: CDK4/6 inhibitor
No prior treatment with a CDK4/6 inhibitor
Cannot have received: oral SERD (elacestrant)
Patients who have received prior treatment with elacestrant or other investigational oral SERD
Cannot have received: mTOR inhibitor (everolimus, temsirolimus, ridaforolimus)
Patients who have received prior treatment with...everolimus, temsirolimus, ridaforolimus or another mTOR inhibitor
Cannot have received: CDK4/6 inhibitor
Patients who have received prior treatment with...any CDK4 and CDK6 inhibitor
Lab requirements
Blood counts
Absolute neutrophil count ≥1500/mm3 (≥1.5 × 10^3/μL); Platelets ≥100,000/μL; Hemoglobin ≥9.0 g/dL
Kidney function
Creatinine clearance (CrCl) ≥ 50 mL/min using the Cockcroft-Gault formula
Liver function
Total bilirubin ≤1.5 ×ULN (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled); AST and ALT ≤2.5 × ULN (≤5 × ULN for participants with liver metastases); Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 x ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy or due to prophylactic coagulation); Serum albumin ≥3.0 g/dL (≥30 g/L)
Have adequate laboratory values as defined below: Hematologic: Absolute neutrophil count ≥1500/mm3 (≥1.5 × 10^3/μL); Platelets ≥100,000/μL; Hemoglobin ≥9.0 g/dL. Renal: Creatinine clearance (CrCl) ≥ 50 mL/min using the Cockcroft-Gault formula. Hepatic: Total bilirubin ≤1.5 ×ULN (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled); AST and ALT ≤2.5 × ULN (≤5 × ULN for participants with liver metastases); Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 x ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy or due to prophylactic coagulation); Serum albumin ≥3.0 g/dL (≥30 g/L)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Basking Ridge · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth · Middletown, New Jersey
- Memorial Sloan Kettering Bergen · Montvale, New Jersey
- Memorial Sloan Kettering Commack · Commack, New York
- Memorial Sloan Kettering Westchester · Harrison, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07209449 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CDK4/6 inhibitor, oral SERD, mTOR inhibitor disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 overexpression is a required biomarker for enrollment.
Does this trial require TP53?
Yes, TP53 wild-type is a required biomarker for enrollment.
Are patients with MMR alterations eligible?
No. MMR deficient is an exclusion criterion.
Are patients with POLE alterations eligible?
No. POLE mutation is an exclusion criterion.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages