Trials / Completed
CompletedNCT04500587
Phase 1 First in Human Study of ZN-d5 as a Single Agent
Phase 1 First in Human Dose-Escalation Study of ZN-d5 as a Single Agent in Subjects With Non-Hodgkin Lymphoma or Acute Myeloid Leukemia
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase 1 dose escalation study of ZN-d5 in subjects with relapsed or refractory non-Hodgkin lymphoma (NHL) or acute myeloid leukemia (AML).
Detailed description
This is an open-label multicenter Phase 1 dose escalation study evaluating the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of the novel BCL-2 inhibitor ZN-d5 in subjects with (NHL) or (AML) in order to determine the recommended phase 2 dose of ZN-d5.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ZN-d5 | Oral agent; 25 mg or 100 mg formulation |
Timeline
- Start date
- 2020-10-13
- Primary completion
- 2023-12-12
- Completion
- 2023-12-12
- First posted
- 2020-08-05
- Last updated
- 2024-09-19
Locations
14 sites across 7 countries: Australia, Bulgaria, Croatia, Poland, South Korea, Spain, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04500587. Inclusion in this directory is not an endorsement.