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    DRUG:

    rogocekib (CTX-712)

    i
    Other names: CTX-712
    Company:
    Chordia Therap
    Drug class:
    pan-CLK inhibitor
    Related drugs:
    2ms
    Discovery of Rogocekib (CTX-712): A Potent and Selective CLK Inhibitor for Cancer Treatment. (PubMed, ACS Med Chem Lett)
    Treatment with CTX-712 reduced the phosphorylation of serine- and arginine-rich proteins in a dose-dependent manner, leading to potent in vitro cell growth suppression and in vivo antitumor activity in lung cancer NCI-H1048 xenograft model. These findings highlight the promise of CTX-712 as a novel CLK inhibitor and its potential as a therapeutic for cancers, particularly those characterized by RNA splicing alterations.
    Journal
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    CDK1 (Cyclin-dependent kinase 1)
    |
    rogocekib (CTX-712)
    2ms
    Phase I Study of Rogocekib in Patients with Relapsed or Refractory Hematologic Malignancies. (PubMed, Blood Adv)
    This study was registered on the Japan Registry of Clinical Trials under jRCT2080224127. Currently, a Phase I/II Study of rogocekib in relapsed/refractory AML and higher risk MDS is ongoing in the United States (NCT05732103).
    P1 data • Journal
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    CDK1 (Cyclin-dependent kinase 1)
    |
    rogocekib (CTX-712)
    2ms
    CTX-712-CL-02: A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes (clinicaltrials.gov)
    P1/2, N=225, Recruiting, Chordia Therapeutics, Inc. | N=170 --> 225 | Trial completion date: Apr 2028 --> Feb 2029 | Trial primary completion date: Apr 2026 --> Jun 2028
    Enrollment change • Trial completion date • Trial primary completion date
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    rogocekib (CTX-712)
    2years
    Phase 1/2 Multicenter, Open-Label Study of CTX-712 in Patients with Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes (ASH 2023)
    Use of azole antifungals that are not strong CYP3A4 inhibitors (e.g., isavuconazole) is permitted. The phase 2 part of the study will commence after the RP2D has been identified and confirmed and aims at evaluating therapeutic activity in R/R AML (Cohort 2a) or R/R HR-MDS (Cohort 2b), in addition to confirmation of the safety profile. Clinical trial registry number: NCT05732103
    Clinical • P1/2 data
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    CDK1 (Cyclin-dependent kinase 1)
    |
    rogocekib (CTX-712)
    3years
    A First-in-Human Phase I Study of CTX-712 in Patients with Advanced, Relapsed or Refractory Malignant Tumors - Hematologic Malignancies Dose Escalation Cohort (ASH 2022)
    Assessment of CTX-712 safety profile for hematologic malignancies is ongoing. CTX-712 showed preliminary anti-tumor efficacy for both AML and MDS.
    Clinical • P1 data
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    SF3B1 (Splicing Factor 3b Subunit 1) • SRSF2 (Serine and arginine rich splicing factor 2) • U2AF1 (U2 Small Nuclear RNA Auxiliary Factor 1) • CDK1 (Cyclin-dependent kinase 1) • ZRSR2 (Zinc Finger CCCH-Type, RNA Binding Motif And Serine/Arginine Rich 2)
    |
    SF3B1 mutation • SRSF2 mutation • U2AF1 mutation
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    rogocekib (CTX-712)