Phase 1 First in Human Study of ZN-d5 as a Single Agent

Korábbi kezelés

• 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.
• Prior therapy with venetoclax.

Más betegség

• Active central nervous system disease.
• Clinically substantial myocardial impairment.

• 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.