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A Study Evaluating the Safety and Efficacy of IBI188 in Combination With AZA in Subjects With Newly Diagnosed MDS

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04511975
Recruitment Status : Suspended (pause for further assessment and study adjustment)
First Posted : August 13, 2020
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Study Description
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Brief Summary:
This is an open-label, phase 1b study to evaluate the safety, tolerability and preliminary efficacy of IBI188 in combination with Azacitidine in newly diagnosed higher risk MDS patients.

Condition or disease Intervention/treatment Phase
MDS Drug: IBI188 Drug: Azacitidine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (MDS)
Actual Study Start Date : August 24, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : April 4, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Azacitidine

Arms and Interventions
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Arm Intervention/treatment
Experimental: IBI188 + azacitidine
Participants will receive IBI188 in combination with azacitidine
 Drug: IBI188
IBI188: 100 mg/mL, intravenous infusion once a week

Drug: Azacitidine
Azacitidine (VIDAZA) for Injection:100 mg per vial, subcutaneous injection will be administered for 7 days in each 28 day cycle
Other Name: VIDAZA


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 28 days ]
    Adverse events according to national Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 or customized AE severity grading as defined in the protocol

  2. Efficacy of IBI188 in combination with AZA [ Time Frame: 28 days ]
    International Working Group (IWG) 2006 criteria will be used to evaluate efficacy of IBI188 in combination with AZA for response criteria for MDS


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

Main Inclusion Criteria:

  1. Newly diagnosed MDS subjects with higher risk.
  2. Age ≥ 18 years old.
  3. Eastern Cooperative Oncology Group score of 0-2.
  4. Adequate organ function.
  5. Subjects should take effective contraceptive measures.
  6. Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.

Main Exclusion Criteria:

  1. Subject who has transformed from MDS to AML.
  2. MDS subjects with lower risk.
  3. Subjects who have received chemotherapy.
  4. History of chronic hemolytic anemia
  5. Prior exposure to any anti-CD47 or anti-SIRPα agents.
  6. Subjects participating in another interventional clinical 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): NCT04511975


Locations
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United States, Maryland
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States, 20817
United States, New Jersey
New Jersey Center for Cancer Research
Brick, New Jersey, United States, 08724
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
Investigators
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Study Director: Yi Luo Innovent Biologics
More Information
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT04511975    
Other Study ID Numbers: CIBI188A103
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020

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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.:
MDS
Additional relevant MeSH terms:
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Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors