Trials / Active Not Recruiting
Active Not RecruitingNCT04150887
Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia
An Open-label, Multicenter, Phase 1b Study of OV-1001 (Cusatuzumab; Anti-CD70 Monoclonal Antibody) in Combination With Background Therapy for the Treatment of Subjects With Acute Myeloid Leukemia
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- OncoVerity, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to characterize safety and tolerability of cusatuzumab in combination with various therapies used to treat acute myeloid leukemia (AML).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cusatuzumab | Cusatuzumab will be administered as a dose of 10mg/kg or 20mg/kg intravenously. |
| DRUG | Azacitidine | Azacitidine will be administered 75 mg/m\^2 subcutaneously or intravenously. |
| DRUG | Venetoclax | Venetoclax will be administered orally and the dose will ramp-up to 400 mg. |
Timeline
- Start date
- 2019-12-23
- Primary completion
- 2026-05-15
- Completion
- 2026-05-15
- First posted
- 2019-11-05
- Last updated
- 2025-04-17
Locations
23 sites across 5 countries: United States, Canada, Germany, Poland, Switzerland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04150887. Inclusion in this directory is not an endorsement.