A PHASE 1/2 DOSE ESCALATION STUDY OF THE BCL-2 INHIBITOR ZN-d5 AND THE WEE1 INHIBITOR ZN-c3 IN SUBJECTS WITH ACUTE MYELOID LEUKEMIA ZN-d5-004C

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Acute Myleloid Leukemia
  • Age: Between 18 Year(s) - 99 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    In order to participate in the study the following conditions must be met:
    1. Histologically or cytologically confirmed AML, as defined by World Health Organization (WHO) 2016 revised criteria (Döhner 2017), including secondary and therapy-related AML. a. Dose-escalation and ZN-c3 monotherapy cohort: subjects must be relapsed from or refractory to one or more prior lines of therapy which can include induction chemotherapy, stem cell transplant, or salvage therapy. For the ZN-c3 monotherapy cohort, the subject should not be a candidate for a recommended available venetoclax-based regimen. b. Expansion Cohort A: subjects must be relapsed from or refractory to one or more prior lines of therapy which can include induction chemotherapy, stem cell transplant, or salvage therapy but not venetoclax or any experimental BCL-2 inhibitor. c. Expansion Cohort B: subjects must be relapsed from or refractory to venetoclax monotherapy or in combination with HMAs or LDAC as initial treatment for AML.
    2. Adequate organ function: a. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3 × upper limit of normal (ULN), or =5 × ULN if leukemic disease in the liver. b. Alkaline phosphatase =5 × ULN. c. Total bilirubin =1.5 × ULN, or =3 × ULN if Gilbert syndrome or if leukemic disease in the liver.
    3. Women of childbearing potential (pre-menopausal or within one year of menopause, unless surgically sterile or serum follicle-stimulating hormone [FSH] is consistent with infertility) must have a negative serum pregnancy test during screening.

You may not be eligible for this study if the following are true:

  • You will not be able to participate in the study if you have had:
    1. Known active CNS involvement (leukemic blasts in cerebrospinal fluid or imaging evidence of CNS disease).
    2. Diagnosis of acute promyelocytic leukemia.
    3. Any of the following treatments or procedures within the specified time frame prior to the initiation of treatment with the study drugs, until discontinuation from study treatment: a. Systemic cytotoxic or non-cytotoxic anti-neoplastic agents, including investigational agents, within the shorter of 21 days or 5 half-lives, other than (1) permitted cytoreductive therapies and (2) intrathecal CNS prophylaxis within 3 days of the first dose of study drugs (Section 6.8.3). b. Hematopoietic stem cell transplant within 60 days, provided no graft-versus-host disease that is of Grade 2 or higher or that has required treatment with systemic immunosuppressive agents within 28 days of the first dose of study drugs. c. Donor lymphocyte infusions within 5 days of the first dose of study drugs.



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