Clinical Trials /

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

NCT04511975

Description:

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.

Related Conditions:
  • Myelodysplastic Syndromes
Recruiting Status:

Suspended

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study Evaluating the Safety and Efficacy of IBI188 in Combination With AZA in Subjects With Newly Diagnosed MDS
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: CIBI188A103
  • NCT ID: NCT04511975

Conditions

  • MDS

Interventions

DrugSynonymsArms
IBI188IBI188 + azacitidine
AzacitidineVIDAZAIBI188 + azacitidine

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
IBI188 + azacitidineExperimentalParticipants will receive IBI188 in combination with azacitidine
  • IBI188
  • Azacitidine

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Adverse Events
Time Frame:28 days
Safety Issue:
Description: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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Innovent Biologics (Suzhou) Co. Ltd.

Trial Keywords

  • MDS

Last Updated

August 27, 2020