- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04338659
A Phase 1a Study Evaluating the Safety, Tolerability, and Efficacy of IBI322 in Subjects With Advanced Cancers
October 6, 2023 updated by: Innovent Biologics (Suzhou) Co. Ltd.
A Phase 1a Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Advanced Malignant Tumors
This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A Phase 1a study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with advanced malignant tumors
Study Type
Interventional
Enrollment (Actual)
22
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 Locations
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California
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Los Angeles, California, United States, 90025
- The Angeles Clinic and Research Institute
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Kansas
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Westwood, Kansas, United States, 66205
- The University of Kansas Cancer Center
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Mississippi
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Jackson, Mississippi, United States, 39313
- University of Mississippi Medical Center
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Texas
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Houston, Texas, United States, 77030
- The University of Texas MD Anderson Cancer Center - Investigational Cancer Therapies
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-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
- At least one evaluable lesion in Part A or at least one measurable lesion in Part B.
- Male or female subject > 18 years old.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Must have adequate organ function including the following.
- Subjects with life expectancy ≥ 12 weeks.
- 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.
- Willing to sign informed consent form and be able to comply with the study's rules and visits/related procedures.
Exclusion Criteria:
- Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
- Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
- Subjects who are on anticoagulants and/or require concomitant aspirin or other nonsteroids anti-inflammatory medications.
- 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.
- 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.
- 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.
- 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
- Subjects who received whole pelvic radiotherapy prior to the enrollment.
- Subjects with known cerebrospinal metastases and other known central nervous system metastases.
- 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).
- Known history of primary immunodeficiency.
- Known history of active pulmonary tuberculosis.
- Known history of allogenic organ transplantation and hematopoietic stem cell transplantation.
- Known history of hypersensitivity to any components of the IBI322 injection.
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: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose Limiting Toxicity (DLT)
Time Frame: .Day 1 - Day 21
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.Day 1 - Day 21
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Treatment-related Adverse Events (TRAEs)
Time Frame: Day 1 - 90 days after last administration
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Day 1 - 90 days after last administration
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive rate of ADA and Nab
Time Frame: Up to 90 days post last dose
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Up to 90 days post last dose
|
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PK parameters
Time Frame: Up to 90 days post last dose
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The area under the curve (AUC)
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Up to 90 days post last dose
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PK parameters
Time Frame: Up to 90 days post last dose
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Maximum concentration (Cmax)
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Up to 90 days post last dose
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PK parameters
Time Frame: Up to 90 days post last dose
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Time at which maximum concentration (Tmax)
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Up to 90 days post last dose
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PK parameters
Time Frame: Up to 90 days post last dose
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The half-life (t1/2)
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Up to 90 days post last dose
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Positive rate of Circulating Immune Complex
Time Frame: Through study completion, an average of 1 year
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Through study completion, an average of 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 14, 2021
Primary Completion (Actual)
February 28, 2023
Study Completion (Actual)
February 28, 2023
Study Registration Dates
First Submitted
March 24, 2020
First Submitted That Met QC Criteria
April 7, 2020
First Posted (Actual)
April 8, 2020
Study Record Updates
Last Update Posted (Actual)
October 10, 2023
Last Update Submitted That Met QC Criteria
October 6, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIBI322A102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
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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