NCT05256472

A Study of AK104 Monotherapy or AK104 Plus Axitinib in Advanced/Metastatic Renal Cell Carcinoma

Phase II Trial of Cadonilimab (AK104) Monotherapy or AK104 Plus Axitinib in Advanced/Metastatic Renal Cell Carcinoma (RCC)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, open-label trial to evaluate the efficacy and safety of AK104 monotherapy or AK104 in combination with axitinib as a first-line treatment for advanced/metastatic renal cell carcinoma (RCC). There are two parts in this trial. In part 1 of this study, subjects with unresectable advanced clear cell or non-clear cell renal cell carcinoma (ccRCC or nccRCC) who had not received systemic therapy for advanced disease will be enrolled to randomly received three different dosage of AK104 monotherapy. In part 2 of this study, subjects with unresectable advanced clear cell renal cell carcinoma (ccRCC) who had not received systemic therapy for advanced disease will be enrolled to receive AK104 plus Axitinib. All subjects will receive treatment until disease progression, development of unacceptable toxicity, death, a decision by the physician or patient to withdraw from the trial. The primary endpoint is ORR per RECIST v1.1 as assessed by investigators.

Conditions

• Renal Cell Carcinoma
• First-line Treatment

Interventions

Type	Name	Description
DRUG	AK104	anti-PD-1/CTLA-4 bi-specific antibody drug; RP2D intravenously (IV)
DRUG	axitinib	an oral, small molecule, TKI selective for VEGFRs 1, 2 and 3; 5mg bid orally

Timeline

• Start date: 2023-07-06
• Primary completion: 2025-12-31
• Completion: 2026-06-22
• First posted: 2022-02-25
• Last updated: 2025-03-06

Locations

1 site across 1 country: China