NCT06472895

A Study of AK112 Monotherapy in Advanced/Metastatic Renal Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single arm , Ib/II phase trial to evaluate the efficacy and safety of AK112（ivonescimab）monotherapy as first-line treatment for favourable risk advanced/metastatic renal cell carcinoma (a/m RCC). Subjects will receive AK112 until disease progression, unacceptable toxic effects, death，a decision by the physician or patient to withdraw from the trial，or AK112 exposure over 2 years. The study set dose exploration stage and dose expansion stage respectively. Firstly, include a few subjects for observation in dose exploration stage, and select appropriate dose to enter expansion, then continue to include more subjects to further assessment.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	AK112 monotherapy	A novel PD-1/VEGF bispecific antibody; RP2D intravenously (IV)，Q3W

Timeline

• Start date: 2024-07-20
• Primary completion: 2025-12-20
• Completion: 2027-12-20
• First posted: 2024-06-25
• Last updated: 2024-06-25