Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS

February 14, 2023 updated by: Innovent Biologics (Suzhou) Co. Ltd.

A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome

The study is to evaluate safety and efficacy of IBI188 in combination with azacitidine (AZA) as a first-line treatment in subjects with newly diagnosed higher risk myelodysplastic syndrome

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

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 Contact

Study Contact Backup

Study Locations

  • China
      • Tianjin, China
        • Blood Diseases Hospital Chinese Academy Of Medical Science

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. MDS subjects with higher risk;
  2. Age ≥ 18 years old;
  3. Eastern Cooperative Oncology Group score of 0~1;
  4. Not suitable for or refuse to receive HSCT;
  5. Newly diagnosed MDS subjects;
  6. Adequate organ function;
  7. Subjects should take effective contraceptive measures
  8. Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.

Exclusion Criteria:

  1. Subject who has transformed from MDS to AML.
  2. Therapy-related MDS (t-MDS), myeloproliferative neoplasm (MPN)- transformed MDS,MDS/MPN.
  3. MDS subjects with lower risk.
  4. Subjects who have received chemotherapy.
  5. Prior exposure to any anti-CD47 or anti-SIRPα agents.
  6. Subjects participating in another interventional clinical study.

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IBI188+azacitidine
Drug: IBI188+azacitidine

Escalating and maintenance dose of IBI188 will be administered 30mg/kg, IV(intravenous infusion),Q4W

Drug:Azacitidine Azacitidine will be administered daily for 7 days, IH, Q4W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: 24 months
To evaluate the safety and tolerability of IBI188 combined with Azacitidine (AZA) in first-line treatment of Myelodysplastic syndrome (MDS)
24 months
Complete response rate (CR) and duration of complete response (DoCR)
Time Frame: 24 months
Complete response rate (CR) and duration of complete response (DoCR) in high-risk MDS subjects with IBI188 combined with AZA as first-line therapy evaluated by the central laboratory.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate (CR) and duration of complete response (DoCR)
Time Frame: 24 months
Complete response rate (CR) and duration of complete response (DoCR) in high-risk MDS subjects with IBI188 combined with AZA as first-line therapy evaluated by the investigators;
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

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)

September 30, 2020

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

August 20, 2024

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

July 21, 2020

First Posted (Actual)

July 24, 2020

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI188C301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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