Actively Recruiting
Study to Evaluate the Preliminary Efficacy of SKB264 and the Effect of Clarithromycin on the PK of SKB264 in OC
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-11
20
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label study to evaluate the preliminary efficacy of SKB264 and the effect of clarithromycin on the PK of SKB264 in patients with ovarian epithelial cancer.
CONDITIONS
Official Title
Study to Evaluate the Preliminary Efficacy of SKB264 and the Effect of Clarithromycin on the PK of SKB264 in OC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 75 years at the time of consent
- Histologically or cytologically confirmed recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer
- Able to provide tumor tissue samples
- At least one measurable lesion
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate bone marrow, liver, kidney, and coagulation function
- Females of childbearing potential must agree to use effective contraception from consent until 6 months after last dose
- Voluntary agreement to participate with ability to comply with study visits and procedures
You will not qualify if you...
- Local recurrence suitable for surgery
- Previous bone marrow radiation
- Ovarian, fallopian tube, or primary peritoneal cancer of non-epithelial origin or other pathological types
- Known brain metastases
- History of other malignancies within 3 years before first administration
- Serious cardiovascular or cerebrovascular diseases or risk factors
- Uncontrolled systemic disease
- History of non-infectious interstitial lung disease or pneumonitis requiring steroids
- Severe dry eye syndrome, meibomian gland disease, blepharitis, or severe corneal disorders preventing corneal healing
- Serious pulmonary function impairment
- Active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, perforation, abscess, or acute hemorrhage
- Active gastrointestinal disease or conditions affecting drug absorption or metabolism
- Risk of esophagotracheal or esophagopleural fistula or tumor invasion/compression of vital organs
- Toxicities from prior anti-tumor therapy not recovered to Grade 1 or less
- Known active pulmonary tuberculosis
- History of allogeneic organ or hematopoietic stem cell transplant
- Active hepatitis B or C
- Positive HIV test, history of AIDS, or active syphilis infection
- Known hypersensitivity to study drugs or components
- Major surgery within 4 weeks before first dose or expected during study
- Serious infection within 4 weeks before first dose
- Prior treatment with TROP2-targeted therapy or topoisomerase I inhibitors
- Use of drugs affecting CYP3A enzyme within 2 weeks before first dose or within 5 half-lives
- Systemic anti-tumor therapy within 4 weeks before first dose or within 5 half-lives
- Use of approved traditional Chinese medicine with anti-tumor effects within 2 weeks before first dose
- Live vaccine within 4 weeks before first dose or planned during study
- Systemic glucocorticoid or immunosuppressive therapy within 2 weeks before first dose
- Participation in other clinical studies receiving study drugs
- Pregnant or lactating women
- Rapid deterioration before first dose
- Local or systemic diseases caused by non-malignant tumors
- Any condition interfering with study evaluation or participant safety as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangdong, Guangzhou, China, 510050
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here