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Lead
K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Phase 1 First in Human Study of ZN-d5 as a Single Agent
