NCT05246995

A Phase I Study of IBI325 in Patients With Advanced Solid Tumor

A Phase I, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI325, an Anti-CD73 Antibody, Combined With Sintilimab in Patients With Advanced Solid Tumor

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 combined with Sintilimab in patients with advanced solid tumors

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	IBI325+Sintilimab	IBI325 + sintilimab combination does-escalation Patients will receive IBI325 monotherapy on Cycle 1 Day 1 ,and then receive IBI325 and sintilimab combination until progressive disease, intolerability, or other reasons leading to treatment discontinuation

Timeline

• Start date: 2022-03-23
• Primary completion: 2023-03-23
• Completion: 2023-11-23
• First posted: 2022-02-18
• Last updated: 2022-02-18

Locations

1 site across 1 country: China