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

October 20, 2023 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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

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

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

222

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Acute promyelocytic leukemia, myeloid sarcoma, acute heterozygous leukemia, CMML(accelerated phase and blast phase).
  2. A history of myeloproliferative diseases (including myelofibrosis, primary thrombocytosis, and true red) Cytosis, chronic myelocytic leukemia) or acute myeloid white blood with BCR-ABL1 translocation Patients.
  3. Major surgery and vaccine treatment within 4 weeks.
  4. Uncontrolled concurrent diseases.
  5. Pregnant or breastfeeding female subjects.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IBI188+azacitidine
1L unfit AML receive IBI188 every week by intravenous(IV) and azacitidine daily in Day 1-7 of each four weeks(Q4W) by subcutaneous(IH)
Drug: IBI188
anti-CD47 Monoclonal antibody
Drug: Azacitidine
Demethylation drugs
Experimental: IBI188+decitabine
R/R AML receive IBI188 every week by intravenous(IV) and decitabine daily in Day 1-10 of each four weeks(Q4W) by subcutaneous(IH)
Drug: IBI188
anti-CD47 Monoclonal antibody
Drug: Decitabine
Demethylation drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite complete rate
Time Frame: 24 weeks
Composite CR including complete remission rate and morphologic complete remission with incomplete blood count recovery
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Cytogenetic CR
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2020

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

July 21, 2020

First Posted (Actual)

July 24, 2020

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI188B201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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