NCT06577961

Vorolanib Combined With Cadonilimab in the Treatment of Untreated Advanced RCC Patients

Study on the Efficacy and Safety of Vorolanib Combined With Cadonilimab in the Treatment of Untreated Advanced RCC Patients

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the efficacy and safety of vorolanib combined with cadonilimab in the treatment of untreated advanced RCC patients.

Detailed description

This study is a multicenter, prospective, phase I/II single-arm trial, aiming to enroll 37 untreated patients with advanced or metastatic ccRCC to receive vorolanib combined with cadonilimab treatment, and to perform CTC/ctDNA testing on subjects. In the phase I dose exploration phase, a 3+3 dose escalation method is used to explore the safety of vorolanib at the standard dose combined with cadonilimab within one treatment cycle, and to determine the dose. In the phase II trial phase, the dosage of vorolanib is determined by the optimal tolerated dose found in the phase I trial, while cadonilimab is combined for treatment. Patients need to be evaluated for efficacy and safety after every 2 treatment cycles (within ±3 days at the end of each cycle), and continue treatment until disease progression, intolerable toxicity, or completion of the prescribed treatment cycle.

Conditions

• Kidney Cancer
• RCC
• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Vorolanib	stage Ⅰ：Vorolanib 200mg QD stage Ⅱ：Vorolanib RP2D QD
DRUG	cadonilimab	stageⅠ：cadonilimab 10mg/kg Q3W stageⅡ：cadonilimab 10mg/kg Q3W

Timeline

• Start date: 2024-08-31
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2024-08-29
• Last updated: 2024-08-29