NCT07087158

A Study of IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma

A Multicenter, Randomized, Open-Label, Active-Controlled Phase II Study Evaluating the Efficacy and Safety of IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Imbioray (Hangzhou) Biomedicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, open-label, active-controlled Phase II clinical study evaluating the efficacy and safety of IBR854 combined with Pazopanib versus Pazopanib in Advanced Renal Cell Carcinoma.

Detailed description

This is a multicenter, randomized, open-label, active-controlled study. Eligible patients with Advanced Renal Cell Carcinoma who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned in a 2:1 ratio to either the experimental arm or the control arm. * Experimental arm: IBR854 in combination with Pazopanib * Control arm: Pazopanib The primary endpoint is PFS per RECIST 1.1. Efficacy and safety datas will be continuously collected until criteria for discontinuation are met.

Conditions

• Renal Cell Carcinoma (RCC)

Interventions

Type	Name	Description
DRUG	IBR854	Every 21 days is one cycle, and IBR854 will be dosed in a route of intravenous infusion on day 1 and day 8 of each cycle with a fixed dose of 9.0×10\^9 cells.
DRUG	Pazopanib	Pazopanib will be dosed orally once daily without food (at least 1 hour before or 2 hours after a meal) with a fixed dose of 800mg.

Timeline

• Start date: 2025-08-10
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-07-25
• Last updated: 2025-07-28

Locations

1 site across 1 country: China