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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:
    5d
    Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov)
    P2, N=39, Recruiting, Peking Union Medical College | Trial primary completion date: Jul 2026 --> Jul 2028
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    carboplatin • Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Piqray (alpelisib) • Irene (pyrotinib) • albumin-bound paclitaxel • abiraterone acetate • fulvestrant • Aidixi (disitamab vedotin) • exemestane • Padcev (enfortumab vedotin-ejfv) • bicalutamide • Kaitanni (cadonilimab) • goserelin acetate • Qibeian (iparomlimab/tuvonralimab) • Yidafan (ivonescimab) • iparomlimab (QL1604) • leuprolide acetate for depot suspension • Entyvio (vedolizumab)
    8d
    A Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line Treatment for Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Huazhong University of Science and Technology
    New P2 trial
    |
    Fruzaqla (fruquintinib) • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)
    8d
    A Clinical Study of Iparomlimab and Tuvonralimab Combined With SOX Following Heterogeneous Radiotherapy as First-line Treatment for Unresectable Locally Advanced or Metastatic HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P4, N=55, Not yet recruiting, Huazhong University of Science and Technology
    New P4 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    oxaliplatin • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)
    11d
    Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Nab-Paclitaxel in Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=26, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    albumin-bound paclitaxel • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)
    14d
    Neoadjuvant Therapy With Iparomlimab and Tuvonralimab, Lenvatinib and Chemotherapy in Resectable ESCC (clinicaltrials.gov)
    P2, N=33, Not yet recruiting, Changhai Hospital
    New P2 trial
    |
    cisplatin • carboplatin • Lenvima (lenvatinib) • albumin-bound paclitaxel • epacadostat (INCB024360) • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)
    1m
    Iparomlimab and Tuvonralimab Plus Hypofractionated Radiotherapy and Chemotherapy for HAHNSCC (clinicaltrials.gov)
    P2, N=27, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University
    New P2 trial • Tumor mutational burden
    |
    EGFR (Epidermal growth factor receptor)
    |
    cisplatin • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)
    1m
    A Clinical Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and Alternating Triweekly CAPOX/mCAPIRI Regimen as First-line Treatment for Unresectable Advanced Colorectal Cancer (clinicaltrials.gov)
    P2, N=70, Not yet recruiting, Jiangsu Cancer Institute & Hospital
    New P2 trial
    |
    MSI (Microsatellite instability)
    |
    Avastin (bevacizumab) • capecitabine • oxaliplatin • irinotecan • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)
    1m
    Neoadjuvant therapy of iparomlimab and tuvonralimab combined with chemotherapy-extenuated for locally advanced cervical cancer (NICE-CC): an investigator-initiated, multicentre, open-label, phase II trial. (PubMed, J Gynecol Oncol)
    A total of 43 patients diagnosed with International Federation of Gynecology and Obstetrics 2018 stage IB3, IIA2, IIB, or IIIC1r will receive iparomlimab and tuvonralimab (5 mg/kg, intravenously), nab-paclitaxel (60 mg/m², intravenously), and cisplatin (75-80 mg/m², intravenously) for the first cycle. Additionally, the exploratory endpoint will focus on identifying predictive biomarkers associated with tumor response. ClinicalTrials.gov Identifier: NCT07055399.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    cisplatin • albumin-bound paclitaxel • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)
    2ms
    A Prospective Phase II Clinical Study of Immunotherapy Combined With Chemotherapy for Stage III Unresectable Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=33, Recruiting, Jiangsu Cancer Institute & Hospital | Not yet recruiting --> Recruiting
    Enrollment open • Tumor mutational burden • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    carboplatin • paclitaxel • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)
    2ms
    First-line Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma With Dual Immunotherapy Combined With Chemotherapy (clinicaltrials.gov)
    P2, N=64, Not yet recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    docetaxel • oxaliplatin • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)
    2ms
    CAPOX and Bevacizumab With or Without Primary Tumor Radiotherapy and Iparomlimab and Tuvonralimab as First-line Treatment for RAS-Mutant/MSS Metastatic Rectal Cancer (clinicaltrials.gov)
    P2, N=106, Not yet recruiting, Peking University Cancer Hospital & Institute
    New P2 trial • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    KRAS mutation • BRAF mutation • NRAS mutation • BRAF V600
    |
    Avastin (bevacizumab) • capecitabine • oxaliplatin • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)
    2ms
    Iparomlimab and Tuvonralimab Injection Combined With SBRT in Patients With Early-Stage Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=28, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)