Status:
COMPLETED
Phase 1 First in Human Study of ZN-d5 as a Single Agent
Lead Sponsor:
K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
Conditions:
Acute Myeloid Leukemia
Non Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 subj...
Eligibility Criteria
Inclusion
- Key
- NHL: relapsed or refractory NHL including DLBCL, FL, MZL, MCL, LCL, LPL and PTC
- Subjects must have received at least 2 prior lines of therapy and have either failed or not be eligible for any available therapies expected to provide clinical benefit and have measurable disease.
- AML: Primary, secondary, or treatment-related AML, relapsed or refractory to prior therapy, which may include failure of one cycle of induction therapy.
- White blood cell count \< 25 × 109/L. Cytoreduction prior to treatment is acceptable.
- Subjects may not be pregnant and must agree to use an effective method of contraception.
- Eastern Cooperative Oncology Group performance status ≤ 2.
- Estimated life expectancy of at least 12 weeks.
- Adequate hematologic and organ function, including creatinine clearance ≥ 60 mL/min.
- Key
Exclusion
- Recent interventions including major surgery, radiation therapy, stem cell transplant.
- Treatment with anti-neoplastic agents with 5 half-lives.
- Significant unresolved toxicity from prior treatments including active GVHD.
- Active central nervous system disease.
- Clinically substantial myocardial impairment.
- Prior therapy with venetoclax.
Key Trial Info
Start Date :
October 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2023
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04500587
Start Date
October 13 2020
End Date
December 12 2023
Last Update
September 19 2024
Active Locations (14)
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1
Site 2708
Darlinghurst, New South Wales, Australia
2
Site 2704
Liverpool, New South Wales, Australia
3
Site 2710
Kurralta Park, South Australia, Australia
4
Site 2709
Hobart, Tasmania, Australia