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    DRUG:

    TheraCIM (nimotuzumab)

    i
    Other names: DE-766, h-R3, OSAG101, anti-EGFR mAb hR3, DE 766, DE766, OSAG-101, OSAG 101
    Company:
    Biocon, Biotech Pharma, Daiichi Sankyo
    Drug class:
    EGFR inhibitor
    Related drugs:
    3d
    HRS-4642 combined with Nimotuzumab in the treatment of recurrent or metastatic pancreatic ductal adenocarcinoma with KRAS G12D mutation that has failed systemic therapy (ChiCTR2500098420)
    P1/2, N=20, Recruiting, West China Hospital,Sichuan University; West China Hospital,Sichuan University | N=10 --> 20
    Enrollment change
    |
    KRAS (KRAS proto-oncogene GTPase) • CA 19-9 (Cancer antigen 19-9)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    TheraCIM (nimotuzumab) • HRS-4642
    3d
    A prospective, randomized, parallel controlled clinical trial of megestrol acetate oral suspension in patients with locally advanced nasopharyngeal carcinoma (ChiCTR2500114759)
    P=N/A, N=68, Not yet recruiting, Fujian Cancer Hospital; Fujian Cancer Hospital
    New trial
    |
    megestrol • TheraCIM (nimotuzumab)
    3d
    A Real-World Study Comparing the Efficacy of Nimotuzumab Combined with Concurrent Chemoradiotherapy and Concurrent Chemoradiotherapy Alone in Patients with High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck After Surgery (ChiCTR2500111656)
    P=N/A, N=194, Not yet recruiting, Peking University Shenzhen Hospital; Peking University Shenzhen Hospital
    New trial
    |
    TheraCIM (nimotuzumab)
    3d
    A Prospective, Single-Arm, Phase II Clinical Study of Nimotuzumab Combined with Tislelizumab as Neoadjuvant Therapy for Patients with Locally Advanced Head and Neck Squamous Cell Carcinoma Who Are Intolerant to Platinum-Based Chemotherapy (ChiCTR2600116769)
    P4, N=48, Not yet recruiting, Beijing Cancer Hospital; Beijing Cancer Hospital
    New P4 trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    EGFR positive
    |
    Tevimbra (tislelizumab-jsgr) • TheraCIM (nimotuzumab)
    3d
    Radiotherapy combined with nimotuzumab versus radiotherapy alone in patients with platinum-intolerant locally advanced head and neck squamous cell carcinoma (ChiCTR2500114545)
    P3, N=335, Not yet recruiting, Shandong First Medical University Affiliated Cancer Hospital; Shandong First Medical University Affiliated Cancer Hospital
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    TheraCIM (nimotuzumab)
    3d
    Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer (ChiCTR2500114031)
    P2, N=156, Not yet recruiting, Peking University Cancer Hospital & Institute; Peking University Cancer Hospital & Institute
    New P2 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    gemcitabine • albumin-bound paclitaxel • TheraCIM (nimotuzumab)
    3d
    A prospective, single arm, phase II clinical study of nimotuzumab combined with concurrent radiotherapy in the treatment of moderate risk patients after head and neck squamous cell carcinoma surgery (ChiCTR2500112384)
    P2, N=63, Not yet recruiting, Tianjin Cancer Hospital; Tianjin Cancer Hospital
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    Erbitux (cetuximab) • TheraCIM (nimotuzumab)
    3d
    Antibody-Targeted Artificial T Cell and Natural Killer Cell Derived Vesicles for Cancer Immunotherapy. (PubMed, J Extracell Vesicles)
    We targeted T and NK92 ACDVs to cancer cells possessing the xenoantigen, N-glycolyl neuraminic acid GM3 ganglioside, using the 14f7hT antibody or the tumour antigen, epidermal growth factor receptor, using the nimotuzumab antibody...14F7hT-conjugated NK92 ACDVs showed cytotoxic activity against chronic lymphocytic leukaemia biopsies. This research shows the potential for using antibody-conjugated, cytotoxic T and NK ACDVs as a feasible and effective approach for tumour-targeted immunotherapy.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • FASLG (Fas ligand) • GZMA (Granzyme A)
    |
    EGFR expression
    |
    TheraCIM (nimotuzumab)
    6d
    Paired Agent Imaging to Evaluate the Improvement of Affinity-Matured Nimotuzumab K4 and K5 Variants as EGFR-Detecting Optical Imaging Agents. (PubMed, Mol Pharm)
    Near-infrared fluorescent imaging was used to quantitate the relative amount of each antibody present in tumors and organs. Paired agent imaging allowed us to detect differences in in vivo fluorescence between K4, K5, and nimotuzumab, where K5 had the highest accumulation in the tumor, followed by K4 and nimotuzumab.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR positive
    |
    TheraCIM (nimotuzumab)
    10d
    Iparomlimab and Tuvonralimab Combined With Nimotuzumab in Recurrent or Metastatic NPC After First-line Treatment Failure: A Single-arm Phase IIa Clinical Trial (clinicaltrials.gov)
    P2, N=41, Recruiting, Sun Yat-sen University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    TheraCIM (nimotuzumab) • Qibeian (iparomlimab/tuvonralimab) • iparomlimab (QL1604)
    12d
    Neoadjuvant Treatment Modalities in Esophageal Cancer (clinicaltrials.gov)
    P3, N=2000, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Trial completion date: Dec 2025 --> Dec 2030 | Trial primary completion date: Dec 2025 --> Dec 2030
    Trial completion date • Trial primary completion date
    |
    paclitaxel • 5-fluorouracil • TheraCIM (nimotuzumab)
    12d
    Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer (clinicaltrials.gov)
    P3, N=2000, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Trial completion date: Dec 2025 --> Dec 2030 | Trial primary completion date: Dec 2025 --> Dec 2030
    Trial completion date • Trial primary completion date
    |
    paclitaxel • 5-fluorouracil • TheraCIM (nimotuzumab)