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A Phase 1a Study Evaluating the Safety, Tolerability, and Efficacy of IBI322 in Subjects With Advanced Cancers

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: NCT04338659
Recruitment Status : Recruiting
First Posted : April 8, 2020
Last Update Posted : August 24, 2022
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 cancer subjects who failed standard treatment.

Condition or disease Intervention/treatment Phase
Advanced Malignant Tumors Lymphomas Biological: IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection Phase 1

Detailed Description:
A Phase 1a study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with advanced malignant tumors
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: N/A
Intervention Model: Sequential 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
Actual Study Start Date : January 14, 2021
Estimated Primary Completion Date : December 28, 2022
Estimated Study Completion Date : July 29, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation of IBI322
Participants will receive escalating dose levels of IBI322 to determine maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of IBI322
 Biological: IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection
IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection
Other Name: IBI322


Outcome Measures
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Primary Outcome Measures :
  1. Dose Limiting Toxicity (DLT) [ Time Frame: .Day 1 - Day 21 ]
  2. Treatment-related Adverse Events (TRAEs) [ Time Frame: Day 1 - 90 days after last administration ]

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

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

  3. PK parameters [ Time Frame: Up to 90 days post last dose ]
    Time at which maximum concentration (Tmax)

  4. PK parameters [ Time Frame: Up to 90 days post last dose ]
    The half-life (t1/2)

  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 ]

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

Inclusion Criteria:

  1. Subjects with histologically/cytologically confirmed unresectable or metastatic solid tumors or relapsed/recurrent lymphomas for which there are no available therapies known to confer clinical benefit.
  2. At least one evaluable lesion in Part A or at least one measurable lesion in Part B.
  3. Male or female subject > 18 years old.
  4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  5. Must have adequate organ function including the following.
  6. Subjects with life expectancy ≥ 12 weeks.
  7. Female subjects of childbearing age or male subjects whose partners are women at childbearing age, need to use 2 highly effective contraceptive measures, including one barrier method, throughout the treatment period and 6 months after the treatment period.
  8. Willing to sign informed consent form and be able to comply with the study's rules and visits/related procedures.

Exclusion Criteria:

  1. Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
  2. Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
  3. Subjects who are on anticoagulants and/or require concomitant aspirin or other nonsteroids anti-inflammatory medications.
  4. Subjects who have a history of blood transfusion within 2 weeks prior to screening, or the use of erythropoietin (EPO), granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage-colony stimulating factor (GM-CSF), thrombopoietin (TPO) or IL-11 therapy.
  5. Subjects who received the last dose of antineoplastic therapy (chemotherapy, endocrine therapy, targeted therapy, immunotherapy or tumor embolization) within 4 weeks prior to the first dose of study drug. Subjects who received the last dose of radiotherapy within 3 weeks prior to the first dose of study drug.
  6. Subjects that received immunosuppressive drugs within 7 days prior to the first dose of study drug, excluding topical, intra-nasal, or inhaled glucocorticoids or systemic glucocorticoids (i.e. equivalent to no more than 10 mg prednisone/day) or other glucocorticoids of equivalent dosage through nasal spray, inhalation or other routes.
  7. Any ongoing AEs Grade 2 or higher as per NCI CTCAE v5.0 directly attributed to prior anti-tumor treatment with the exception of residual hair loss and fatigue
  8. Subjects who received whole pelvic radiotherapy prior to the enrollment.
  9. Subjects with known cerebrospinal metastases and other known central nervous system metastases.
  10. Subjects with active or suspected autoimmune diseases or with a history of documented autoimmune disease over the past 2 years (subjects can be included in the study: vitiligo, psoriasis, alopecia or Grave's disease subjects who do not require systemic treatment within 2 years; hypothyroidism subjects who require only thyroid hormone replacement therapy, and type I diabetes subjects who require only insulin replacement therapy).
  11. Known history of primary immunodeficiency.
  12. Known history of active pulmonary tuberculosis.
  13. Known history of allogenic organ transplantation and hematopoietic stem cell transplantation.
  14. Known history of hypersensitivity to any components of the IBI322 injection.
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): NCT04338659


Contacts
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Contact: Innovent Global Trial Director +1-301-578-2600 ext 2 Global.Development@Innoventbio.com

Locations
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United States, California
The Angeles Clinic And Research Institute Recruiting
Los Angeles, California, United States, 90025
United States, Kansas
The University of Kansas Cancer Center Recruiting
Westwood, Kansas, United States, 66205
United States, Mississippi
University Of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39313
United States, Texas
The University of Texas MD Anderson Cancer Center - Investigational Cancer Therapies Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
More Information
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT04338659    
Other Study ID Numbers: CIBI322A102
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: August 24, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Innovent Biologics (Suzhou) Co. Ltd.:
Cancer, advanced malignancy, metastatic, solid tumor, lymphoma
Additional relevant MeSH terms:
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Neoplasms
Antibodies
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs