NCT05119998

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• 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 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 and sintilimab until progressive disease, intolerability, or other reasons leading to treatment discontinuation
DRUG	IBI325	IBI325 monotherapy does-escalation Patients will receive IBI325 until progressive disease, intolerability, or other reasons leading to treatment discontinuation

Timeline

• Start date: 2022-02-08
• Primary completion: 2023-07-27
• Completion: 2023-08-08
• First posted: 2021-11-15
• Last updated: 2023-08-18

Locations

1 site across 1 country: China