CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS

A Phase I Combination Study of CYC065 and Venetoclax in Patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes

A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory AML or MDS

This is an open-label, single arm, dose escalation study in patients with relapsed or refractory AML or MDS. Treatment will be administered on an outpatient basis and all patients will receive CYC065 over 4-hour infusion once every 2 weeks on Day 1 and Day 15 in combination with venetoclax. One treatment cycle is 4 weeks.

Inclusion Criteria:

• Previously treated AML or MDS based on WHO classification and having at least 10% blasts in peripheral blood
• ECOG 0-2
• Adequate renal function
• Adequate liver function
• INR <=1.2 in patients not receiving chronic anticoagulation
• At least 2 weeks from prior cytotoxic chemotherapy, radiation therapy, major surgery or other investigational cancer therapy
• Agree to practice effective contraception

Exclusion Criteria:

• AML is of the subtype of APL or extramedullary myeloid tumor without bone marrow involvment
• Known AML involvement in CNS that is symptomatic and active
• Currently receiving radiotherapy, biological therapy, or any other investigational agents
• Uncontrolled intercurrent illness
• Pregnant or lactating
• Known to be HIV-positive
• Known active hepatitis B and/or hepatitis C infection