Efficacy and Safety Evaluation of IBI188 in Combination With Azacitidine in Treatment of Patients With Acute Myeloid Leukemia

Sponsor

Innovent Biologics (Suzhou) Co. Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04485052

Collaborator

(none)

126

Enrollment

Location

Arm

19.2

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is to evaluate safety， tolerability and composite CR of IBI188 plus azacitidine in acute myeloid leukemia

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: IBI188 Drug: Azacitidine	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

126 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Acute Myeloid Leukemia

Actual Study Start Date :

Sep 25, 2020

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IBI188+azacitidine Participants receive IBI188 every four weeks(Q4W) by intravenous(IV) and azacitidine daily in Day1-7 of each four weeks(Q4W) by subcutaneous(IH)	Drug: IBI188 IBI188 will be administered 30mg/kg, IV (intravenous infusion), Q4W Drug: Azacitidine Azacitidine will be administered 75mg/m^2 according to body surface area (BSA) daily for 7 days, IH (hypodermic injection), Q4W

Arm

Intervention/Treatment

Experimental: IBI188+azacitidine

Participants receive IBI188 every four weeks(Q4W) by intravenous(IV) and azacitidine daily in Day1-7 of each four weeks(Q4W) by subcutaneous(IH)

Drug: IBI188

IBI188 will be administered 30mg/kg, IV (intravenous infusion), Q4W

Drug: Azacitidine

Azacitidine will be administered 75mg/m^2 according to body surface area (BSA) daily for 7 days, IH (hypodermic injection), Q4W

Outcome Measures

Primary Outcome Measures

Composite complete rate [24 weeks]
Composite CR including complete remission rate and morphologic complete remission with incomplete blood count recovery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

AML patients diagnosed according to WHO AML diagnostic criteria in 2016 (except M3-type and BCR-ABL positive AML).
Relapsed// refractory AML( ≥18 ys) or newly diagnosed elderly AML unfit for intensive chemotherapy( ≥60 ys).
Age ≥18 years old, gender not limited.
ECOG score of 0-2.
Adequate organ function.

Exclusion Criteria:

Acute promyelocytic leukemia, myeloid sarcoma, acute heterozygous leukemia, CMML(accelerated phase and blast phase).
Prior exposure to any anti-CD47 or anti-SIRPα agents.
Major surgery and vaccine treatment within 4 weeks.
Uncontrolled concurrent diseases.
Pregnant or breastfeeding female subjects.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China

Sponsors and Collaborators

Innovent Biologics (Suzhou) Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Innovent Biologics (Suzhou) Co. Ltd.

ClinicalTrials.gov Identifier:

NCT04485052

Other Study ID Numbers:

CIBI188B201

First Posted:

Jul 24, 2020

Last Update Posted:

Oct 20, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Azacitidine

Study Results

No Results Posted as of Oct 20, 2020