Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment Refractory/Intolerant CML Failing ≥3 Prior CML Therapies

• Status: Recruiting
• Trial end date: 2026-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Criteria

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

• 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 (Part C).

Exclusion Criteria:

• Presence of T315I (PART C)

• 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