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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 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)
    3d
    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)
    3d
    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)
    23d
    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)
    24d
    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)
    1m
    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)
    1m
    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)
    1m
    A Phase II Clinical Study of Sequential Iparomlimab and Tuvonralimab Combined with Chemotherapy Following Local Radiotherapy in Breast Cancer Patients with Poor Response to Neoadjuvant Chemotherapy (ChiCTR2600117206)
    P=N/A, N=30, Not yet recruiting, The Fourth Hospital of Hebei Medical University; The Fourth Hospital of Hebei Medical University
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    carboplatin • albumin-bound paclitaxel • epirubicin • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)
    1m
    Study on the efficacy and safety of QL1706 combined with Senaparib in neoadjuvant therapy for ovarian Cancer: A prospective, single-arm clinical study (ChiCTR2600116175)
    P=N/A, N=20, Not yet recruiting, The Fourth Hospital of Hebei Medical University; Fourth Hospital of Hebei Medical University
    New trial
    |
    Paishuning (senaparib) • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)
    1m
    A single-center, single-arm clinical study on the efficacy and safety of Iparomlimab and Tuvonralimab combined with chemotherapy as neoadjuvant therapy in patients with muscle-Invasive bladder cancer (MIBC) (ChiCTR2500115561)
    P=N/A, N=20, Not yet recruiting, Tianjin Cancer Hospital Airport Hospita; Tianjin Cancer Hospital Airport Hospita
    New trial
    |
    carboplatin • albumin-bound paclitaxel • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)
    1m
    Prospective, Open-Label, Single-Center Clinical Study of Iparomlimab and Tuvonralimab Combined with AG Regimen plus SBRT versus Epalolitovorimab Combined with AG Regimen as First-Line Treatment for Unresectable Locally Advanced or Metastatic Pancreatic Cancer (ChiCTR2500115120)
    P=N/A, N=40, Not yet recruiting, The First Affiliated Hospital of University of science and technology of China; The First Affiliated Hospital of University of science and technology
    New trial
    |
    gemcitabine • albumin-bound paclitaxel • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)
    1m
    Iparomlimab and Tuvonralimab combined with chemotherapy as second-line treatment for locally advanced or metastatic pancreatic cancer A prospective, open-label, single-arm clinical study (ChiCTR2500114040)
    P=N/A, N=29, Not yet recruiting, Harbin medical university cancer hospital; Harbin medical university cancer hospital
    New trial
    |
    5-fluorouracil • irinotecan • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)