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    DRUG:

    ompenaclid (RGX-202)

    i
    Other names: RGX-202, RGX202, RGX 202, RGX-202-01
    Company:
    EMD Serono, Inspirna
    Drug class:
    SLC6A8 inhibitor
    14d
    A Study to Investigate Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Advanced/Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=70, Active, not recruiting, Inspirna, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Aug 2028 --> Dec 2026 | Trial primary completion date: Aug 2026 --> Sep 2025
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR • RAS mutation
    |
    Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • ompenaclid (RGX-202)
    6ms
    RGX-202-001: A Study of RGX-202-01 (Ompenaclid) as Combination Therapy in RAS Mutant Advanced Colorectal Cancer (clinicaltrials.gov)
    P1, N=108, Recruiting, Inspirna, Inc. | N=60 --> 108 | Trial primary completion date: Dec 2023 --> Dec 2024
    Enrollment change • Trial primary completion date • Combination therapy • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR • RAS mutation
    |
    Avastin (bevacizumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • ompenaclid (RGX-202)
    7ms
    A Study to Investigate Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Advanced/Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=70, Recruiting, Inspirna, Inc. | N=50 --> 70
    Enrollment change • Combination therapy • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR • RAS mutation
    |
    Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • ompenaclid (RGX-202)
    12ms
    A Study to Investigate Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Advanced/Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, Inspirna, Inc.
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR • RAS mutation
    |
    Avastin (bevacizumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • ompenaclid (RGX-202)
    1year
    A Study to Investigate Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Advanced/Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, Inspirna, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR • RAS mutation
    |
    Avastin (bevacizumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • ompenaclid (RGX-202)
    over1year
    A Study to Investigate Response to Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Patients With Advanced or Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Inspirna, Inc.
    New P2 trial • Combination therapy • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR • RAS mutation
    |
    Avastin (bevacizumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • ompenaclid (RGX-202)
    over1year
    Phase Ib/II study of ompenaclid (RGX-202-01), afirst-in-class oral inhibitor of the creatine transporter SLC6A8, in combination with FOLFIRI and bevacizumab (BEV) in RAS mutated (RASm) second-line (2L) advanced/metastatic colorectal cancer (mCRC) (ESMO 2023)
    Eligible pts had disease progression after a 1L oxaliplatin-containing regimen...There is a high unmet need for a safe and combinable oral pan-RASm therapy in mCRC. Recruitment of RASm pts continues and a randomized controlled trial in 2L RASm mCRC is planned.
    Clinical • P1/2 data • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • CKB (Creatine Kinase B)
    |
    KRAS G12D • KRAS G13D • RAS mutation • KRAS G12
    |
    Avastin (bevacizumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • ompenaclid (RGX-202)
    over2years
    A Study of RGX-202-01 as Combination Therapy in 2nd Line RAS Mutant Advanced Colorectal Cancer (clinicaltrials.gov)
    P1, N=60, Recruiting, Inspirna, Inc. | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: May 2023 --> Dec 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR • RAS mutation
    |
    Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • ompenaclid (RGX-202)
    over2years
    A Study of RGX-202-01 as Combination Therapy in 2nd Line RAS Mutant Advanced Colorectal Cancer (clinicaltrials.gov)
    P1, N=60, Recruiting, Inspirna, Inc. | Trial completion date: May 2022 --> Dec 2023 | Trial primary completion date: Dec 2021 --> May 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR • RAS mutation
    |
    Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • ompenaclid (RGX-202)
    over4years
    [VIRTUAL] Phase I monotherapy dose escalation of RGX-202, a first-in-class oral inhibitor of the SLC6a8/CKB pathway, in patients with advanced gastrointestinal (GI) solid tumors. (ASCO 2020)
    Among 17 patients treated with single agent therapy, no DLTs occurred; notably, exposures predicted to be sufficient to inhibit human tumor growth from preclinical models were achieved along with concomitant pharmacodynamic effects. These data, along with a durable PR observed in the highest dose cohort, support further development of RGX-202. Consequently, dose escalation in combination with FOLFIRI in patients with advanced GI cancers is underway with plans for expansion in CKB+ CRC pts.
    Clinical • P1 data
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS G12V • KRAS G13D • KRAS G12 • KRAS G13
    |
    ompenaclid (RGX-202)