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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:
    23h
    NOTABLE-309: Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer (clinicaltrials.gov)
    P2, N=156, Not yet recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P2 trial
    |
    gemcitabine • albumin-bound paclitaxel • TheraCIM (nimotuzumab)
    4d
    Nimotuzumab Plus Gemcitabine-based Adjuvant Chemotherapy for Resectable Pancreatic Cancer: A Retrospective Observational Study. (PubMed, Pancreas)
    By adding nimotuzumab to existing gemcitabine-based AC regimens, RPC patients would show a survival benefit trend with a satisfactory safety profile.
    Observational data • Retrospective data • Journal
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    gemcitabine • TheraCIM (nimotuzumab)
    21d
    HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Zhejiang University
    New P2 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    paclitaxel • TheraCIM (nimotuzumab) • HRS-4642
    25d
    HRS-4642 Combined With Nimotuzumab in the Treatment of Recurrent or Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=20, Recruiting, West China Hospital | N=10 --> 20
    Enrollment change
    |
    TheraCIM (nimotuzumab) • HRS-4642
    1m
    Nimotuzumab plus image-guided radiotherapy for elderly patients with locally advanced cervical squamous cell carcinoma: Interim analysis of a prospective multi-center phase Ⅱ trial. (PubMed, Int J Radiat Oncol Biol Phys)
    Among elderly LACSCC patients, nimotuzumab plus image-guided radiotherapy and brachytherapy was well tolerated and indicated promising clinical survival benefits. The robustness of efficacy and toxicity results might provide a novel treatment option for this population.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    TheraCIM (nimotuzumab)
    1m
    Adiponectin Receptor 1-vascular endothelial growth factor axis mediates resistance to epidermal growth factor receptor-targeted therapy in nasopharyngeal carcinoma. (PubMed, Anticancer Drugs)
    NPC cell lines (5-8F and CNE1) were treated with nimotuzumab for short (24 h) and long (72 h) durations...Prolonged EGFR-targeted therapy in NPC upregulates VEGF via AdipoR1 downregulation, reducing treatment efficacy. Adiponectin restores AdipoR1, suppresses VEGF, and reverses this effect, possibly through mTOR inhibition, suggesting a potential strategy to improve long-term therapeutic outcomes.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • CD36 (thrombospondin receptor) • FABP4 (Fatty Acid Binding Protein 4)
    |
    TheraCIM (nimotuzumab)
    1m
    A Single-Arm, Prospective, Multi-Center Study on the Treatment of Unresectable Locally Advanced/Oligometastatic Pancreatic Cancer Using Iodine-125 Radioactive Particle Implantation Combined with Nimotuzumab and Chemotherapy (ChiCTR2500111167)
    P4, N=58, Not yet recruiting, Qilu Hospital of Shandong University (Qingdao); Qilu Hospital of Shandong University (Qingdao)
    New P4 trial
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    TheraCIM (nimotuzumab)
    1m
    A Randomized, Open-Label, Phase II, Prospective Clinical Study of Nivolumab in Combination with Immunotherapy and Chemotherapy as Neoadjuvant Therapy for Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (ChiCTR2500108221)
    P2, N=98, Not yet recruiting, The First People's Hospital of Foshan; The First People's Hospital of Foshan
    New P2 trial
    |
    Opdivo (nivolumab) • TheraCIM (nimotuzumab)
    1m
    Efficacy of Radiotherapy in Combination with S-1 and Nimotuzumab in Elderly Patients with Esophageal Cancer: A Prospective, Single-Arm Study (ChiCTR2500110571)
    P2, N=60, Completed, Zhejiang Cancer Hospital; Zhejiang Cancer Hospital
    New P2 trial
    |
    Teysuno (gimeracil/oteracil/tegafur) • TheraCIM (nimotuzumab)
    1m
    Nimotuzumab combined with concurrent radiotherapy versus radiotherapy alone in high-risk patients with head and neck squamous cell carcinoma who are not suitable for cisplatin: A multicenter clinical study (ChiCTR2500108772)
    P3, N=95, Completed, Eye and ENT Hospital of Fudan University; Eye and ENT Hospital of Fudan University
    New P3 trial
    |
    cisplatin • TheraCIM (nimotuzumab)
    2ms
    Efficacy of cadonilimab in combination with nimotuzumab and AG regimen in TMB-H/KRAS wild-type advanced pancreatic cancer: a case report. (PubMed, Front Immunol)
    Continued treatment maintained partial remission (PR), with progression-free survival (PFS) lasting over seven months and manageable toxicity. This case highlights the potential of the combination of cadonilimab, nimotuzumab, albumin-bound paclitaxel, and gemcitabine as an effective, low-toxicity treatment option for patients with TMB-H/KRAS wild-type advanced pancreatic cancer.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • TMB (Tumor Mutational Burden) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    KRAS mutation • TMB-H • KRAS wild-type • RAS wild-type
    |
    gemcitabine • albumin-bound paclitaxel • Kaitanni (cadonilimab) • TheraCIM (nimotuzumab)