A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant Tumors
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
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
280 participants
Apr 8, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
SKB518 12mg/kg q3w
AUC 5 q3w
Bevacizumab 15mg/kg q3w
SKB518 10mg/kg q3w
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07448922