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Clinical Trial Summary

This is a Phase 3, multicenter, randomized, open-label trial to evaluate whether EG-007 plus Len+Pem is superior to Len+Pem alone in patients with advanced endometrial cancer (Stage III or IV). This trial will be preceded by a safety lead-in study with up to 28 patients (the safety lead-in is a separate, free-standing protocol). Approximately 450 patients will be randomized equally (1:1) to receive EG-007 plus Len+Pem or Len+Pem alone. The randomization will be stratified by the following stratification factors: - Diagnosis Classification (advanced Stage III/IV vs. recurrent endometrial cancer) - ECOG score at baseline (0 vs 1) - Geographic region (Asia vs ROW)


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05077215
Study type Interventional
Source Evergreen Therapeutics, Inc.
Contact Xin Du, Ph.D.
Phone 2404064016
Email david.du@egpharm.com
Status Not yet recruiting
Phase Phase 3
Start date December 2024
Completion date December 2025

See also
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Not yet recruiting NCT05106127 - Safety Lead-In Study of a Repurposed Drug Added to the Combination of Len Plus Pem Phase 2
Completed NCT01289041 - BKM120 as Second-line Therapy for Advanced Endometrial Cancer Phase 2
Recruiting NCT05481645 - Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus. Phase 2
Not yet recruiting NCT06046274 - GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer Phase 2