Trials / Suspended
SuspendedNCT04485065
Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS
A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome
- Status
- Suspended
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IBI188+azacitidine | Escalating and maintenance dose of IBI188 will be administered 30mg/kg, IV(intravenous infusion),Q4W Drug:Azacitidine Azacitidine will be administered daily for 7 days, IH, Q4W |
Timeline
- Start date
- 2020-09-30
- Primary completion
- 2023-12-30
- Completion
- 2024-08-20
- First posted
- 2020-07-24
- Last updated
- 2023-02-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04485065. Inclusion in this directory is not an endorsement.