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

Phase 1

Completed

• Conditions: Hematologic Malignancy
• Interventions: Biological: IBI322

• Registration Number: NCT04795128
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-12
• Study Start: 2021-05-07
• Primary Completion: 2023-08-15
• Study Completion: 2023-08-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Histologically/cytologically confirmed hematologic malignancy who failed the standard treatment
2. At least one evaluable lesion
3. Male or female 18 to 75 years old
4. Eastern Cooperative Oncology Group Performance Status Performance Status (ECOG PS) 0-2
5. Must have adequate organ function

Exclusion Criteria

1. Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein
2. Previous exposure to chimeric antigen receptor T cell immunotherapy (CAR-T)
3. Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies
4. Use of anticoagulants and/or aspirin, or other non-steroidal anti-inflammatory drugs within 2 weeks prior to study start
5. A history of blood transfusion within 2 weeks prior to study start

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBI322	IBI322	Single arm

Primary Outcome Measures

Name	Time	Method
Number of treatment related AEs	Up to 90 days post last dose	Safety
Number of patients with response	Last patient enrolled +24 weeks	Preliminary Efficacy

Secondary Outcome Measures

Name	Time	Method
Positive Rate of ADA and Nab	Up to 90 days post last dose	Safety and Preliminary Efficacy
PK Parameters: Maximum concentration (Cmax)	Up to 90 days post last dose	Safety and Preliminary Efficacy
PK Parameters: Clearance (CL)	Up to 90 days post last dose	Safety and Preliminary Efficacy
PK Parameters: Volume of Distribution (V)	Up to 90 days post last dose	Safety and Preliminary Efficacy
PK Parameters: Half-life (t1/2)	Up to 90 days post last dose	Safety and Preliminary Efficacy
PK Parameters: The area under the curve (AUC)	Up to 90 days post last dose	Safety and Preliminary Efficacy

Trial Locations

Locations (1)

The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Zhejiang, China