NCT04004442

Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma

Phase I Study of Avelumab in Combination With AXL Inhibitor AVB-S6-500 in Patients With Advanced Urothelial Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to test the safety of avelumab and AVB-S6-500 and see what effects (good and bad) this combination treatment has on patients with advanced urothelial carcinoma.

Detailed description

Patients will have tests and exams to see if they are eligible for the clinical trial. If found eligible, the patient will receive treatment with avelumab and AVB-S6-500 by vein once every two weeks. This study has two parts in order to determine the maximum tolerated dose of AVB-S6-500. If the patient is enrolled on the first dose level, the patient will be treated at a higher dose every two weeks with AVB-S6-500. If the patient is enrolled on the second dose level, the patient will be receive AVB-S6-500 only once a week at a lower dose. The patient would continue to receive avelumab twice weekly at the same dose. Patients will receive the study treatment as long as there is evidence that the tumor is not growing or spreading and they are not having any unacceptable, bad side effects. Patients will be monitored during treatment with tests and exams and after treatment completion for up to one year.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Avelumab	Avelumab: 800 mg IV every two weeks (on days 1 and 15 of a 28-day cycle)
DRUG	AVB-S6-500	AVB-S6-500: 10mg/kg IV every 2 weeks (on days 1 and 15 of a 28-day cycle) Potential dose reduction: AVB-S6-500: 5mg/kg IV weekly (on days 1, 8, 15 and 22 of a 28-day cycle)

Timeline

• Start date: 2020-02-17
• Primary completion: 2022-04-07
• Completion: 2026-10-01
• First posted: 2019-07-02
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study