Overview
Phase 1 dose escalation study of ZN-d5 in subjects with relapsed or refractory non-Hodgkin lymphoma (NHL) or acute myeloid leukemia (AML).
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.
Eligibility
Key Inclusion Criteria:
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 Criteria:
- 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.