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

NCT04795128 | Completed Phase 1

• 1 other identifier: CIBI322A103
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (2)

• Number of treatment related AEs

  Safety

  Up to 90 days post last dose

• Number of patients with response

  Preliminary Efficacy

  Last patient enrolled +24 weeks

Secondary Outcomes (6)

• PK Parameters: The area under the curve (AUC)

  Up to 90 days post last dose

• PK Parameters: Maximum concentration (Cmax)

  Up to 90 days post last dose

• PK Parameters: Half-life (t1/2)

  Up to 90 days post last dose

• PK Parameters: Clearance (CL)

  Up to 90 days post last dose

• PK Parameters: Volume of Distribution (V)

  Up to 90 days post last dose

Study Arms (1)

IBI322

OTHER

Single arm

Biological: IBI322

Interventions

IBI322 BIOLOGICAL

Recombinant anti-human CD47/PD-L1 bispecific antibody injection

IBI322

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Zhejiang, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• WenBin Qian

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 12, 2021
• Study Start: May 7, 2021
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

CN (1)