Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment of Ph+ CML Resistant/Intolerant to ≥3 Prior CML Therapies

Part A Inclusion Criteria: * Healthy males aged 18 to 55 years Part B Key Inclusion Criteria: * Subjects diagnosed with Ph+ CML-CP, Ph+ CML-AP, Ph+ CML-BP, or Ph+ ALL who are refractory or intolerant to at least 3 TKIs or are not eligible (e.g.: due to comorbidities, hypersensitivity to excipients, lack of insurance coverage) for their local country's regulatory approved and medically appropriate TKIs (e.g., a TKI that is effective against mutations in the patient's tumor). Part C Key Inclusion Criteria: * Subjects diagnosed with Ph+ CML-CP, Ph+ CML-AP, Ph+ CML-BP, who are resistant and/or intolerant to ≥ 3 prior TKIs one of which includes ponatinib (Subjects with Ph+ ALL are not included). Part B and C: Other Inclusion Criteria * Willing and able to give written, and dated, informed consent * Male or female aged ≥ 18 years * Willing and able to comply with the scheduled visits * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 Part A Exclusion Criteria: * Any major surgery, as determined by the Investigator, within 4 weeks of IMP administration * Inability to undergo venipuncture and/or tolerate venous access * Positive exclusion tests: HIV, hepatitis B surface antigen, or hepatitis C virus * Known or suspected history of significant drug abuse as judged by the Investigator Part B and C Exclusion Criteria: * Presence of T315I * Any major surgery, as determined by the Investigator, within 4 weeks of IMP administration * Inability to underg…