A Study Evaluating the Safety and Efficacy of IBI188 in C... | NCT04511975

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

NCT04511975

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Status

Suspended

Last Update Posted

Dec 21, 2020Actual

Enrollment

32Estimated

Phase

Phase 1

Conditions

Interventions

IBI188
Azacitidine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

pause for further assessment and study adjustment

Expanded Access Info

Not provided

Start Date

Aug 24, 2020Actual

Primary Completion Date

Oct 31, 2021Estimated

Completion Date

Apr 4, 2022Estimated

First Submitted Date

Aug 5, 2020

First Submission Date that Met QC Criteria

Aug 11, 2020

First Posted Date

Aug 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2020

Last Update Posted Date

Dec 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IBI188 + azacitidine	Experimental	Participants will receive IBI188 in combination with azacitidine	Drug: IBI188 Drug: Azacitidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IBI188	Drug	IBI188: 100 mg/mL, intravenous infusion once a week	IBI188 + azacitidine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Main Inclusion Criteria:

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

Main Exclusion Criteria:

Subject who has transformed from MDS to AML.
MDS subjects with lower risk.
Subjects who have received chemotherapy.
History of chronic hemolytic anemia
Prior exposure to any anti-CD47 or anti-SIRPα agents.
Subjects participating in another interventional clinical study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yi Luo	Innovent Biologics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
American Oncology Partners of Maryland, PA		Bethesda	Maryland	20817	United States
New Jersey Center for Cancer Research

Intervention Browse Module

MeSH Terms

ID	Term
D001374	Azacitidine

Ancestor Terms

ID	Term
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided