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

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)

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.

Study Overview

• Status: Suspended
• Conditions: MDS
• Intervention / Treatment: Drug: IBI188; Drug: Azacitidine

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • American Oncology Partners of Maryland, PA
  • New Jersey
    • Brick, New Jersey, United States, 08724
      • New Jersey Center for Cancer Research
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: VIDAZA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	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	28 days
Efficacy of IBI188 in combination with AZA	International Working Group (IWG) 2006 criteria will be used to evaluate efficacy of IBI188 in combination with AZA for response criteria for MDS	28 days

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Investigators: Study Director: Yi Luo, Innovent Biologics

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2020
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): April 4, 2022

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: MDS
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Azacitidine
• Other Study ID Numbers: CIBI188A103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No