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

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04485065
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 16.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes	Drug: IBI188+azacitidine; Drug: Drug:Azacitidine	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 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 Newly Diagnosed Higher Risk Myelodysplastic Syndrome
• Actual Study Start Date: Sep 30, 2020
• Anticipated Primary Completion Date: Dec 5, 2021
• Anticipated Study Completion Date: Feb 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IBI188+azacitidine	Drug: IBI188+azacitidine; IBI188 will be administered 30mg/kg, IV (intravenous infusion), Q4W Drug:Azacitidine Azacitidine will be administered daily for 7 days, IH, Q4W; Drug: 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

1. Complete response rate [24 weeks]

   Defined as the proportion of subjects with CR as assessed by the central laboratory in the analysis population

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. MDS subjects with higher risk;

2. Age ≥ 18 years old;

3. Eastern Cooperative Oncology Group score of 0~2;

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Blood Diseases Hospital Chinese Academy Of Medical Science	Tianjin		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: NCT04485065
• Other Study ID Numbers: CIBI188C301
• First Posted: Jul 24, 2020
• Last Update Posted: Mar 10, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Innovent Biologics (Suzhou) Co. Ltd.: MDS
• Additional relevant MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome; Azacitidine

Study Results

No Results Posted as of Mar 10, 2021