NCT04200404

A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors

A Phase Ib/II, Multicenter Open-label Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: CStone Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label study of CS1001 in combination with regorafenib in participants with advanced or refractory cancers. There will be a dose escalation portion in "allcomers"to find a suitable dose of regorafenib for combination use with CS1001. This study will also enroll participants with specific tumor types in the phase II part of the study to assess the efficacy, pharmacokinetics and safety of the combined regimen (RP2D of regorafenib + CS 1001)

Conditions

• Advanced Refractory Solid Tumors

Interventions

Type	Name	Description
DRUG	CS1001	One course will last 28 days. CS1001 will be intravenously administered every 4 weeks (Q4W).
DRUG	Regorafenib	One course will last 28 days. Administration will be orally (p.o.) taken at different dose schemes.

Timeline

• Start date: 2019-12-13
• Primary completion: 2021-05-13
• Completion: 2021-08-18
• First posted: 2019-12-16
• Last updated: 2022-05-06

Locations

1 site across 1 country: Australia