NCT06434610

A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.

A Multicenter, Randomized, Double-blind, Parallel-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of B013 Combined With Paclitaxel in the Treatment of Platinum-resistant Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.

Conditions

• Platinum-resistant Recurrent Ovarian Cancer

Interventions

Type	Name	Description
DRUG	B013	B013: The subjects will receive IV dose of B013 600 mg on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.
DRUG	Paclitaxel	Paclitaxel: 80 mg/m\^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle.
DRUG	Placebo	Placebo: The subjects will receive IV dose of placebo matched to B013 on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.

Timeline

• Start date: 2024-07-11
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-05-30
• Last updated: 2025-01-27

Locations

17 sites across 1 country: China