Actively Recruiting
A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant Tumors
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-12
280
Participants Needed
2
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agreement to follow study requirements.
- Female aged 18 to 75 years.
- ECOG Performance Status of 0 or 1 within 2 weeks prior to first dose.
- Confirmed gynecologic malignancy by cytology or histology.
- For ovarian cancer cohort: epithelial ovarian carcinoma treated with 2-4 prior systemic therapies, excluding primary platinum-resistant cases.
- For cervical or endometrial cancer cohort: disease failed or intolerant to standard therapy, or no standard therapy available.
- Platinum-sensitive ovarian cancer cohorts treated with 1-4 prior systemic therapies as specified.
- Participants with BRCA mutations must have received PARP inhibitor therapy unless contraindicated.
- Provide 10-13 unstained tumor tissue slides for gene expression testing.
- At least one measurable target lesion per RECIST v1.1 criteria.
- Estimated life expectancy of at least 12 weeks.
- Adequate bone marrow, liver, kidney, and coagulation function per lab tests.
- Left ventricular ejection fraction (LVEF) of 50% or higher by echocardiography.
- Recovery from prior therapy toxicities to Grade 0 or 1 or to acceptable levels.
- Agree to use highly effective contraception during study treatment.
- Non-pregnant, non-lactating, and meet criteria for women of childbearing potential or not as defined.
You will not qualify if you...
- Participation in other interventional clinical studies recently.
- Ovarian cancer with sarcomatous or borderline tumors.
- Mixed tumors with certain histological types in specified cohorts.
- Prior treatment with topoisomerase I targeting drugs.
- Antineoplastic therapy within 4 weeks or specific washout periods for certain drugs.
- Use of strong CYP3A4 or BCRP inhibitors/inducers within 2 weeks or 5 half-lives.
- Live vaccine within 4 weeks prior or planned during study.
- Unresolved adverse reactions from prior therapy except stable chronic toxicities.
- Major surgery within 4 weeks prior or planned during study.
- Recent palliative or definitive radiotherapy within specified timeframes.
- Systemic corticosteroid or immunosuppressive therapy within 14 days prior.
- Symptomatic CNS metastases or related severe neurological conditions.
- History of significant pulmonary diseases or suspected during screening.
- Active infections requiring treatment recently or serious infections.
- HIV positive or active hepatitis B or C infections.
- Symptomatic COVID-19 infection requiring treatment or hospitalization.
- Active tuberculosis or syphilis infections.
- Certain uncontrolled cardiovascular conditions or severe hypertension.
- Gastrointestinal or tracheal lumen stents.
- Significant malnutrition requiring intravenous nutrition.
- Recent serious thromboembolic events or bleeding.
- Symptomatic effusions requiring intervention.
- Biliary obstruction without successful local treatment.
- Severe liver conditions including hepatic encephalopathy or cirrhosis.
- History or risk of gastrointestinal perforation or obstruction.
- Clinically significant proteinuria.
- Severe eye diseases or conditions preventing adequate monitoring.
- Known hypersensitivity to study drugs or components.
- History of immunodeficiency or organ transplantation.
- Pregnant or lactating women.
- Other malignancies progressing within 5 years requiring treatment, except certain skin and cervical cancers.
- Tumor invasion of vital organs or risk of fistulas.
- Other acute or chronic diseases or conditions increasing study risk or affecting results interpretation.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Chongqing University Cancer Hospital
Chongqing, China
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
X
Xiaoping Jin, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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