RecruitingPhase 2NCT07448922

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


Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Enrollment

280 participants

Start Date

Apr 8, 2026

Study Type

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bevacizumab, a drug called Carboplatin (AUC 5), and others for people with advanced gynecological malignancies. The study is currently recruiting participants at 2 locations.

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

DRUGSKB518 for injection

SKB518 12mg/kg q3w

DRUGCarboplatin (AUC 5)

AUC 5 q3w

DRUGBevacizumab

Bevacizumab 15mg/kg q3w

DRUGSKB518 for injection

SKB518 10mg/kg q3w


Locations(2)

Chongqing University Cancer Hospital

Chongqing, China

Fudan University Shanghai Cancer Center

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT07448922