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Safety and Efficacy of IBI322 in American Subjects With Advanced Malignant Tumors

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. Identifier: NCT04338659
Recruitment Status : Not yet recruiting
First Posted : April 8, 2020
Last Update Posted : April 8, 2020
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

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

Condition or disease Intervention/treatment Phase
Advanced Malignancies Biological: IBI322 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Advanced Malignant Tumors
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
IBI322 Biological: IBI322
Recombinant anti-human CD47/PD-L1 bispecific antibody injection

Primary Outcome Measures :
  1. Number of DLT time [ Time Frame: 28 days ]
  2. Number of treatment related AEs [ Time Frame: 90 days post last dose ]

Secondary Outcome Measures :
  1. PK parameters: The area under the curve (AUC) [ Time Frame: Up to 90 days post last dose ]
  2. PK parameters: Maximum concentration (Cmax) [ Time Frame: Up to 90 days post last dose ]
  3. PK parameters: Time at which maximum concentration (Tmax) [ Time Frame: Up to 90 days post last dose ]
  4. PK parameters: The half-life (t1/2) [ Time Frame: Up to 90 days post last dose ]
  5. Positive rate of ADA and Nab [ Time Frame: Up to 90 days post last dose ]
  6. Positive rate of Circulating Immune Complex [ Time Frame: Through study completion, an average of 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors.
  2. At least one evaluable lesion.
  3. Male or female subject above 18 years old.
  4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
  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 any anti-programmed death receptor 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) /anti-programmed death ligand 2 (PD-L2) antibodies
  3. Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
  4. Patients who are on anticoagulants and /or require concomitant aspirin or other nonsteroids anti-inflammatory medications. Patients with a history of a bleeding diathesis (von Willebrand disease, end stage liver disease, hemophilia, etc.)
  5. Subjects who have a history of blood transfusion within 2 weeks prior to the study.

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 identifier (NCT number): NCT04338659

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Contact: Tong Wu 0512-69566088

Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd. Identifier: NCT04338659    
Other Study ID Numbers: CIBI322A102
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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