NCT07341100

Study to Evaluate the Preliminary Efficacy of SKB264 and the Effect of Clarithromycin on the PK of SKB264 in OC

A Multicenter, Open-label Clinical Study to Evaluate the Preliminary Efficacy of SKB264 and the Effect of Clarithromycin, a Potent CYP3A Inhibitor, on the Pharmacokinetics of SKB264 in Patients With Ovarian Epithelial Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Cycle 1 will be for drug-drug interaction (DDI) assessment. Thereafter, participants will receive SKB264 monotherapy.

Conditions

• Ovarian Epithelial Cancer

Interventions

Type	Name	Description
DRUG	SKB264	4 mg/kg, administered once every 2 weeks (Q2W) by intravenous infusion. It will be administered on Day 1 and Day 17 of Cycle 1, and from Cycle 2 onwards, on Day 1 and Day 15 of each 4-week cycle.
DRUG	Clarithromycin	500 mg administered orally, twice daily (BID) from Day 14 to Day 29 of Cycle 1.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-01-01
• Completion: 2028-06-01
• First posted: 2026-01-14
• Last updated: 2026-01-14