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

September 12, 2022 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

230

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: IBI322
Single arm
Biological: IBI322
Recombinant anti-human CD47/PD-L1 bispecific antibody injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of treatment related AEs
Time Frame: Up to 90 days post last dose
Safety
Up to 90 days post last dose
Number of patients with response
Time Frame: Last patient enrolled +24 weeks
Preliminary Efficacy
Last patient enrolled +24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Investigators

  • Principal Investigator: Wenbin Qian, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2021

Primary Completion (Anticipated)

October 28, 2023

Study Completion (Anticipated)

April 30, 2024

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI322A103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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