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    DRUG:

    iparomlimab (QL1604)

    i
    Other names: QL1604, PSB103, QL-1604, QL 1604
    Company:
    Qilu Pharma
    Drug class:
    PD1 inhibitor
    Related drugs:
    3d
    Iparomlimab (QL1604) in patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) unresectable or metastatic solid tumors: a pivotal, single-arm, multicenter, phase II trial. (PubMed, J Hematol Oncol)
    No iparomlimab-related death occurred. Iparomlimab presented encouraging antitumor activity with durable response and tolerable safety profile.Trial registration ClinicalTrials.gov Identifier: NCT04326829.
    P2 data • Journal • Mismatch repair • Microsatellite instability • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    iparomlimab (QL1604)
    2ms
    Efficacy and Safety of Iparomlimab, an Anti-PD-1 Antibody, in Patients with Advanced Solid Tumors: A Phase 1c Study. (PubMed, Adv Ther)
    Iparomlimab showed preliminary clinical activity and had a manageable safety profile in patients with advanced solid tumors. These results support further investigation of iparomlimab as monotherapy or in combination therapy in advanced solid tumors.
    Journal • Metastases
    |
    PD-1 (Programmed cell death 1)
    |
    iparomlimab (QL1604)
    10ms
    QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer (clinicaltrials.gov)
    P2/3, N=46, Terminated, Qilu Pharmaceutical Co., Ltd. | N=458 --> 46 | Trial completion date: Jul 2022 --> Nov 2023 | Recruiting --> Terminated; Phase 2 completed, phase 3 sponsor decided to terminate
    Enrollment change • Trial completion date • Trial termination • Metastases
    |
    cisplatin • carboplatin • paclitaxel • iparomlimab (QL1604)
    1year
    A single-arm, phase II, multicenter study of iparomlimab (QL1604) in patients (pts) with unresectable/metastatic deficient mismatch repair (dMMR)/microsatellite instability high (MSI-H) solid tumors (ESMO Asia 2023)
    No QL1604-related death occurred. Conclusions QL1604 showed promising efficacy with high response rate and durable response and tolerable toxicity in pts with dMMR/MSI-H solid tumors.
    Clinical • P2 data • Mismatch repair • Microsatellite instability • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    iparomlimab (QL1604)
    almost2years
    QL1604 Monotherapy for dMMR or MSI-H Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=86, Recruiting, Qilu Pharmaceutical Co., Ltd. | Unknown status --> Recruiting | Trial completion date: Jun 2022 --> Jul 2023 | Trial primary completion date: Dec 2020 --> Dec 2022
    Enrollment open • Trial completion date • Trial primary completion date • Mismatch repair • Metastases
    |
    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
    |
    PD-L1 expression • MSI-H/dMMR
    |
    iparomlimab (QL1604)
    over4years
    A Study of QL1604 Plus Nab-paclitaxel Versus Paclitaxel in Subjects With Advanced Gastric Cancer. (clinicaltrials.gov)
    P2/3, N=492, Not yet recruiting, Qilu Pharmaceutical Co., Ltd.
    Clinical • New P2/3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    HER-2 negative
    |
    albumin-bound paclitaxel • iparomlimab (QL1604)
    over4years
    QL1604 Monotherapy for dMMR or MSI-H Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=86, Not yet recruiting, Qilu Pharmaceutical Co., Ltd.
    Clinical • New P2 trial • Mismatch repair
    |
    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
    |
    PD-L1 expression • MSI-H/dMMR
    |
    iparomlimab (QL1604)