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

NCT04511975 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-12-21

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Yi Luo · Innovent Biologics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-24
Primary Completion
2021-10-31
Completion
2022-04-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04511975 on ClinicalTrials.gov