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

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Two-Part Phase 1/2 Study to Determine Safety, Tolerability, Pharmacokinetics, and Activity of K0706, a Novel Tyrosine Kinase Inhibitor (TKI), in Healthy Subjects and in Subjects With Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

ClinicalTrials.gov ID

NCT02629692

Acronym / sponsor ID

CLR_15_03 V 12 Amendment 12

Conditions

Healthy (For Part A), Chronic Myeloid Leukemia (for Part B and C)

Keywords

CML, Chronic Myelogenous Leukemia, K0706, Vodobatinib, ponatinib-refractory/intolerant, treatment refractory chronic myeloid leukemia

Phase

Phase 1/2

Study type

Interventional

Recruitment status

TerminatedReason stopped: Closed for administrative, non-safety-related reasons.

Enrolment

124 participants (actual)

Lead sponsor

Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)

Study start

27 Jun 2016 (actual)

Primary completion

3 Jan 2025 (actual)

Study completion

3 Jan 2025 (actual)

First posted

14 Dec 2015 (estimated)

Results

Posted 13 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Not applicable

Intervention model

Single group

Masking

None (open label)

Number of arms

1

Model description

Part A: Single ascending dose in healthy volunteers. Part B: Multiple ascending dose safety and tolerability study in subjects with CML or Ph + ALL. Part C: Efficacy and safety study in subjects with treatment-resistant CML

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Examination of the Safety and Tolerability of Single Oral Doses of K0706

   Time frame: Approximately 56 ± 2 days

   Number of Participants with Adverse Events in Part A

2. To Determine the Maximum Tolerated Dose (MTD) as Determined by Frequency of Dose Limiting Toxicities

   Time frame: Dose Limiting toxicities observed over a 4 week period

   PART B

3. Incidence and Severity of Treatment Emergent AEs (PART B)

   Time frame: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)

   Number of Participants with treatment emergent Adverse Events in Part B

4. For CML Subjects in CP at Study Entry

   Time frame: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)

   PART C: Proportion of subjects achieving Major Cytogenetic Response [ defined as complete cytogenetic response (CCyR; 0% Ph+metaphases) or partial cytogenetic response (PCyR; 1-35% Ph+ metaphases)] as assessed by conventional Karyotyping of Bone marrow aspirate

5. For CML Subjects in AP at Study Entry

   Time frame: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)

   PART C: Proportion of subjects achieving Major Hematologic Response [ defined as complete hematologic response (CHR) or no evidence of leukemia (NEL)] as assessed by complete blood count of peripheral blood sample

6. For CML Subjects in BP at Study Entry

   Time frame: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)

   PART C: Proportion of subjects achieving Major Hematologic Response [defined as complete hematologic response (CHR) or no evidence of leukemia (NEL)] as assessed by complete blood count of peripheral blood sample

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 39929221Cortes JE, Kim DW, Saikia T, Khattry N, Rathnam K, Alvarado Y, Hannah G, Tantravahi SK, Apperley JF, Charbonnier A, Garcia-Gutierrez V, Lucchesi A, Dima D, Illes A, Popov VM, Abruzzese E, Nag A, Apte S, Badar T, Yao SL, Saxena U, Sreenivasan J, Inamdar S, Chimote G, Nicolini FE. Vodobatinib for patients with Philadelphia chromosome-positive chronic myeloid leukaemia resistant or intolerant to multiple lines of previous therapy: an open-label, multicentre, phase 1/2 trial. Lancet Haematol. 2025 Mar;12(3):e201-e213. doi: 10.1016/S2352-3026(24)00354-5. Epub 2025 Feb 7.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

35 sites in 10 countries: see every site and its status.