^
10ms
Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment of Ph+ CML Resistant/Intolerant to ≥3 Prior CML Therapies (clinicaltrials.gov)
P1/2, N=122, Active, not recruiting, Sun Pharma Advanced Research Company Limited | Recruiting --> Active, not recruiting | N=303 --> 122 | Trial primary completion date: Jan 2026 --> Aug 2026
Enrollment closed • Enrollment change • Trial primary completion date
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
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vodobatinib (SCO - 088)
12ms
Management of Chronic Myeloid Leukemia Patients in Later Lines: The Role of Ponatinib and New Compounds. (PubMed, Clin Lymphoma Myeloma Leuk)
Recently approved by FDA, the first-of-its-kind STAMP inhibitor asciminib has proven safe and effective, obtaining deep and stable molecular responses even in heavily pretreated patients and with T315I mutation...Among these, novel agents such as vodobatinib and olverembatinib have provided promising result in clinical trials, representing valuable therapeutic possibilities in intolerant or refractory patients. Therefore, a more complex therapeutic paradigm is expected in the near future.
Review • Journal
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Iclusig (ponatinib) • Scemblix (asciminib) • Nailike (olverembatinib) • vodobatinib (SCO - 088)
over1year
Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment Refractory/Intolerant CML Failing ≥3 Prior CML Therapies (clinicaltrials.gov)
P1/2, N=303, Recruiting, Sun Pharma Advanced Research Company Limited | Trial primary completion date: Aug 2022 --> Jan 2026
Trial primary completion date
|
ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
|
vodobatinib (SCO - 088)
over2years
An Update of Safety and Efficacy Results from Phase 1 Dose-Escalation and Expansion Study of Vodobatinib, a Novel Oral BCR-ABL1 Tyrosine Kinase Inhibitor (TKI), in Patients with Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Failing Prior TKI Therapies (ASH 2021)
Vodobatinib continues to be associated with favourable long term safety and efficacy in heavily pre-treated CML failing ≥ 3 prior TKIs, including ponatinib. Phase 2 study evaluating vodobatinib in pts failing at least 3 prior lines of therapy, including ponatinib, is ongoing.
Clinical • P1 data
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
|
ABL1 T315I • BCR-ABL1 mutation
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Iclusig (ponatinib) • vodobatinib (SCO - 088)
over2years
Journal
|
ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
|
Scemblix (asciminib) • Nailike (olverembatinib) • Hansoh Xinfu (flumatinib) • PF-114 • vodobatinib (SCO - 088)
4years
BCR-ABL1 tyrosine kinase inhibitor K0706 exhibits pre-clinical activity in Philadelphia chromosome-positive leukemia. (PubMed, Exp Hematol)
K0706 is a novel BCR-ABL1 TKI currently under clinical investigation with structural elements similar to those of ponatinib and dasatinib. We demonstrate that while K706 retains efficacy against a large spectrum of clinically relevant mutations, it does not appear to have activity against BCR-ABL1T315I. Early trial experience suggests excellent tolerability, which may positively impact the place of K0706 within the ever-expanding CML treatment paradigm.
Journal
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ABL1 (ABL proto-oncogene 1)
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dasatinib • Iclusig (ponatinib) • vodobatinib (SCO - 088)
over4years
Phase 1 Trial of K0706, a Novel Oral BCR-ABL1 Tyrosine Kinase Inhibitor (TKI): In Patients with Chronic Myelogenous Leukemia (CML) and Phildelphia Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Failing ≥ 3 Prior TKI Therapies: Initial Safety and Efficacy (ASH 2019)
Introduction: Despite availability of several BCR-ABL1 TKIs for treatment of CML, some patients (pts) fail ≥3 TKIs and/or have co-morbidities that limit use of 2nd generation TKIs (2GTKI: Nilotinib, Dasatinib and Ponatinib). K0706 has acceptable safety profile with activity in heavily pre-treated patients who had failed at least ≥3 prior lines of TKIs. The study provides early proof of principle for the effectiveness of K0706 in a setting with few available treatment options.
Clinical • P1 data
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ABL1 (ABL proto-oncogene 1)
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dasatinib • Iclusig (ponatinib) • Tasigna (nilotinib) • vodobatinib (SCO - 088)