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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04795128
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Study Description
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Brief Summary:
This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in hematologic malignancy subjects who failed standard treatment.

Condition or disease Intervention/treatment Phase
Hematologic Malignancy Biological: IBI322 Phase 1

Detailed Description:
Phase 1a/1b study will be conducted to evaluate the tolerability, safety, PK, PD, immunogenicity and preliminary antitumor activity of IBI322 in China. Phase 1a is dose escalation and plans to enroll approximately 39-102 subjects with hematologic malignancy who failed the standard treatment. Phase 1b is dose expansion, and plans to enroll approximately 80 subjects with hematologic malignancy.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy
Actual Study Start Date : May 7, 2021
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : November 4, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
IBI322
Single arm
 Biological: IBI322
Recombinant anti-human CD47/PD-L1 bispecific antibody injection


Outcome Measures
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Primary Outcome Measures :
  1. Number of treatment related AEs [ Time Frame: Up to 90 days post last dose ]
    safety

  2. Number of patients with response [ Time Frame: Last patient enrolled+24 weeks ]
    preliminary efficacy


Secondary Outcome Measures :
  1. PK parameters: The area under the curve (AUC) [ Time Frame: Up to 90 days post last dose ]
    safety and preliminary efficacy

  2. PK parameters: Maximum concentration (Cmax) [ Time Frame: Up to 90 days post last dose ]
    safety and preliminary efficacy

  3. PK parameters: The half-life (t1/2) [ Time Frame: Up to 90 days post last dose ]
  4. PK parameters: Clearance(CL) [ Time Frame: Up to 90 days post last dose ]
  5. PK parameters: Volume of distribution (V) [ Time Frame: Up to 90 days post last dose ]
  6. Positive rate of ADA and Nab [ Time Frame: Up to 90 days post last dose ]
    safety and preliminary efficacy


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically/cytology confirmed, hematologic malignancy who failed the standard treatment.
  2. At least one evaluable lesion.
  3. Male or female subject above 18 years old, no more than 75 years old.
  4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 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. Subjects who are used of anticoagulants and/or aspirin or other non-steroidal anti-inflammatory drugs within 2 weeks prior to the study
  5. Subjects who have a history of blood transfusion within 2 weeks prior to the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04795128


Contacts
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Contact: Min Luo 0512-69566088 min.luo@innoventbio.com

Locations
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China
The Second Affiliated Hospital Zhejiang University School OF Medicine Recruiting
Zhejiang, China
Contact: WenBin Qian    86-0571-89713674    qianwenb@hotmail.com   
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
Investigators
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Principal Investigator: WenBin Qian Second Affiliated Hospital, School of Medicine, Zhejiang University
More Information
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT04795128    
Other Study ID Numbers: CIBI322A103
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases