NCT03312842

A Phase Ia/Ib Study of CS1001 in Subjects With Advanced Solid Tumors

A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 259 (actual)
• Sponsor: CStone Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in subjects with advanced solid tumors.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	CS1001	In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the dose expansion part, patients will be assigned to different groups based on their tumor type.

Timeline

• Start date: 2017-10-19
• Primary completion: 2021-08-16
• Completion: 2022-02-16
• First posted: 2017-10-18
• Last updated: 2022-05-26

Locations

2 sites across 1 country: China