NCT05808608

A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma

Efficacy and Safety of First-Line Cadonilimab Plus Axitinib in Patients With Advanced Special Pathological Type Renal Cell Carcinoma: A Prospective, Multi-center, Phase Ib/II Trial

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Hao Zeng · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ib/II, open-label, single arm trial to evaluate the efficacy and safety of AK104 in combination with axitinib as a first-line treatment for advanced/metastatic special pathological subtypes of renal cell carcinoma (ssRCC). Subjects will receive AK104 plus axitinib until disease progression, development of unacceptable toxic effects, death, a decision by the physician or patient to withdraw from the trial. Primary objective: Phase Ib: To evaluate the safety and tolerability of different doses of cadonilimab combined with axitinib as first-line therapy in subjects with advanced RCC with special pathological types to determine the recommended phase II dose (RP2D). Phase II: To evaluate the objective response rate (ORR) of cadonilumab combined with axitinib as first-line therapy in subjects with advanced RCC with special pathological types according to the RECIST 1.1 criteria.

Conditions

• Renal Cell Carcinoma
• First-line Treatment
• Non Clear Cell Renal Cell Carcinoma
• Sarcomatoid Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	AK104	Anti-PD-1/CTLA-4 bi-specific antibody drug; Phase 1b: 10mg/kg or 15mg/kg; Phase 2: RP2D intravenously (IV)
DRUG	Axitinib	An oral, small molecule, TKI selective for VEGFRs; 5mg bid orally

Timeline

• Start date: 2023-11-17
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2023-04-11
• Last updated: 2026-04-07

Locations

1 site across 1 country: China