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

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
• •Presence of T315I
• •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: urine pregnancy tests (if applicable), HIV, hepatitis B surface antigen, or hepatitis C virus
• •Known or suspected history of significant drug abuse as judged by the Investigator
• •Received any other investigational agent within 30 days or a washout of at least 5 half-lives, whichever is longer of IMP administration
• •Subjects who are eligible for potentially curative therapy that is available, including hematopoietic stem cell transplant
• •Another primary malignancy within the past 3 years or earlier (except for adequately treated non-melanoma skin cancer or cervical cancer in situ