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    DRUG:

    romaciclib (RVU120)

    i
    Other names: RVU120, SEL 120-34A, SEL120, SEL120-34A, SEL-120-34A, SEL12034A, SEL 12034A, SEL-12034A
    Company:
    Ryvu Therap
    Drug class:
    CDK8/19 inhibitor
    Related drugs:
    27d
    Romaciclib, a CDK8/CDK19 inhibitor, can overcome venetoclax resistance through a combinatorial strategy. (PubMed, bioRxiv)
    These findings prove the highly synergistic mechanism of action of RVU120+VEN combination and the potential to overcome primary/acquired VEN resistance in relapse/refractory AML disease. Altogether, the presented results support ongoing clinical studies evaluating romaciclib and VEN in VEN/HMA-refractory patients ( NCT06191263 ) and provide a basis for future exploration as a frontline therapy in VEN-naïve patients.
    Journal
    |
    MCL1 (Myeloid cell leukemia 1) • IL6 (Interleukin 6) • STAT3 (Signal Transducer And Activator Of Transcription 3) • TGFB1 (Transforming Growth Factor Beta 1) • CDK9 (Cyclin Dependent Kinase 9)
    |
    Venclexta (venetoclax) • romaciclib (RVU120)
    4ms
    ROVER-01: RVU120 Rollover Study (clinicaltrials.gov)
    P2, N=10, Not yet recruiting, Ryvu Therapeutics SA | Initiation date: Aug 2025 --> Dec 2025
    Trial initiation date
    |
    romaciclib (RVU120)
    8ms
    ROVER-01: RVU120 Rollover Study (clinicaltrials.gov)
    P2, N=10, Not yet recruiting, Ryvu Therapeutics SA
    New P2 trial
    |
    romaciclib (RVU120)
    9ms
    RIVER-52: Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML (clinicaltrials.gov)
    P2, N=94, Active, not recruiting, Ryvu Therapeutics SA | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    romaciclib (RVU120)
    1year
    RVU120-SOL-021: RVU120 (SEL120) in Patients with Relapse/Refractory Metastatic or Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=120, Active, not recruiting, Ryvu Therapeutics SA | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER expression
    |
    romaciclib (RVU120)
    over1year
    POTAMI-61: RVU120 in Patients with Intermediate or High-risk, Primary or Secondary Myelofibrosis (clinicaltrials.gov)
    P2, N=230, Recruiting, Ryvu Therapeutics SA | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Jakafi (ruxolitinib) • romaciclib (RVU120)
    over1year
    POTAMI-61: RVU120 in Patients With Intermediate or High-risk, Primary or Secondary Myelofibrosis (clinicaltrials.gov)
    P2, N=230, Not yet recruiting, Ryvu Therapeutics SA
    New P2 trial • Combination therapy
    |
    Jakafi (ruxolitinib) • romaciclib (RVU120)
    almost2years
    RIVER-52: Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML (clinicaltrials.gov)
    P2, N=94, Recruiting, Ryvu Therapeutics SA
    New P2 trial
    |
    romaciclib (RVU120)
    almost2years
    REMARK_001: RVU120 for Treatment of Anemia in Patients With Lower-risk Myelodysplastic Neoplasms (clinicaltrials.gov)
    P2, N=41, Not yet recruiting, GCP-Service International West GmbH
    New P2 trial
    |
    romaciclib (RVU120)
    almost2years
    CLI120-001: RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome (clinicaltrials.gov)
    P1, N=112, Active, not recruiting, Ryvu Therapeutics SA | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    romaciclib (RVU120)
    2years
    Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed/Refractory AML (clinicaltrials.gov)
    P2, N=98, Recruiting, Ryvu Therapeutics SA | Trial completion date: Dec 2027 --> Sep 2026 | Trial primary completion date: Jun 2027 --> Feb 2026
    Trial completion date • Trial primary completion date • Combination therapy
    |
    Venclexta (venetoclax) • romaciclib (RVU120)
    2years
    RVU120-SOL-021: RVU120 (SEL120) in Patients With Relapse/Refractory Metastatic or Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=120, Recruiting, Ryvu Therapeutics SA | Trial completion date: Nov 2023 --> May 2025 | Trial primary completion date: Nov 2023 --> May 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER expression
    |
    romaciclib (RVU120)