Clinical Trial

A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant Tumors

Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This is an open-label, multicenter, Phase II clinical study to evaluate the efficacy and safety of SKB518 as monotherapy or combination therapy in patients with advanced gynecological malignancies. This study will include 5 cohorts: SKB518 as monotherapy in advanced ovarian cancer; SKB518 as monotherapy in advanced cervical cancer and endometrial cancer; SKB518 in combination with Carboplatin in advanced ovarian cancer; SKB518 in combination with Carboplatin and Bevacizumab in advanced ovarian cancer; and SKB518 in combination with Bevacizumab in advanced ovarian cancer. Study hypothesis: SKB518 will show meaningful clinical activity and a favorable risk benefit profile in gynecological malignancies.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-05-13
notable Sponsor changed: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. -> Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 2026-05-13
Trial Details
NCT Number NCT07448922
Lead Sponsor Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions Advanced Gynecological Malignancies
Enrollment 280 participants
Start Date 2026-04-08
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-12