NCT04511975

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

A Phase 1b Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (MDS)

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• MDS

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-08-24
• Primary completion: 2021-10-31
• Completion: 2022-04-04
• First posted: 2020-08-13
• Last updated: 2020-12-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study