NCT04795128

A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy

A Phase I Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with hematologic malignancies who have failed standard treatment.

Detailed description

This Phase 1a/1b study will be conducted to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of IBI322 in China. Phase 1a is a dose escalation and plans to enroll approximately 39-102 subjects with hematologic malignancies who have failed standard treatments. Phase 1b is a dose expansion and plans to enroll approximately 80 subjects with hematologic malignancies.

Conditions

• Hematologic Malignancy

Interventions

Type	Name	Description
BIOLOGICAL	IBI322	Recombinant anti-human CD47/PD-L1 bispecific antibody injection

Timeline

• Start date: 2021-05-07
• Primary completion: 2023-08-15
• Completion: 2023-08-15
• First posted: 2021-03-12
• Last updated: 2024-11-06

Locations

1 site across 1 country: China