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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:
    16h
    Nimotuzumab Combined With Concurrent Curative Radiotherapy and S-1 in 75 Years and Older Patients With Stage II-IVB Esophageal Squamous Cell Carcinoma: A Phase II Study. (PubMed, Int J Cancer)
    Among survivors, 45.5% reported high satisfaction with their QOL, and 84.8% did not experience weight loss. This combination therapy demonstrated promising efficacy and safety, suggesting it may be a viable treatment option for this patient population.
    P2 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    TheraCIM (nimotuzumab)
    25d
    A multicenter, single-arm phase II clinical study of eribulin combined with inituzumab and pyrotinib in the treatment of HER2-positive advanced breast cancer (ChiCTR2600121825)
    P2, N=76, Recruiting, Fifth Affiliated Hospital, Sun Yat-Sen University; Fifth Affiliated Hospital, Sun Yat-Sen University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Irene (pyrotinib) • Halaven (eribulin mesylate) • TheraCIM (nimotuzumab)
    25d
    A Prospective, Single-Arm, Phase II Study of Nimotuzumab Combined with Sintilimab and Neoadjuvant Chemotherapy in the Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma (ChiCTR2600120859)
    P2, N=36, Recruiting, Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital; Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital
    New P2 trial
    |
    Tyvyt (sintilimab) • TheraCIM (nimotuzumab)
    25d
    A Prospective, Single-Arm Study of Nimotuzumab plus Camrelizumab, Irinotecan Liposome (II) and Raltitrexed as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Cancer (ChiCTR2600119939)
    P=N/A, N=42, Chongqing Medical University First Affiliated Hospital; Chongqing Medical University First Affiliated Hospital
    New trial
    |
    AiRuiKa (camrelizumab) • TheraCIM (nimotuzumab) • Tomudex (raltitrexed)
    25d
    A Phase II Clinical Study of Induction Therapy with EGFR Monoclonal Antibody (Nimotuzumab) Combined with Gemcitabine and S-1 for Locally Advanced Nasopharyngeal Carcinoma in Patients Intolerant to Cisplatin (ChiCTR2600118783)
    P2, N=28, The First Affiliated Hospital of Xiamen University; The First Affiliated Hospital of Xiamen University
    New P2 trial
    |
    cisplatin • gemcitabine • Teysuno (gimeracil/oteracil/tegafur) • TheraCIM (nimotuzumab)
    1m
    NimoBenSeq: Postoperative Radiotherapy With Nimotuzumab ± Benmelstobart in Intermediate-Risk Head and Neck Squamous Cell Carcinoma: A Randomized Controlled Trial (clinicaltrials.gov)
    P2/3, N=386, Not yet recruiting, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
    New P2/3 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Andewei (benmelstobart) • TheraCIM (nimotuzumab)
    1m
    Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=370, Recruiting, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    cisplatin • bemcentinib (BGB324) • Andewei (benmelstobart) • TheraCIM (nimotuzumab)
    2ms
    Case Report: A case of severe hypotension induced by nimotuzumab in a nasopharyngeal carcinoma patient. (PubMed, Front Immunol)
    After discontinuing the drug and giving continuous norepinephrine to increase BP, the patient's BP returned to stable. This case suggests that although nimotuzumab-related hypotension is mostly mild and reversible, BP monitoring should still be strengthened to maintain vigilance against severe hypotension and intervene promptly in clinical practice.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression • EGFR positive
    |
    TheraCIM (nimotuzumab)
    2ms
    Concurrent chemoradiotherapy plus nimotuzumab versus chemoradiotherapy alone for locoregionally advanced nasopharyngeal carcinoma with a suboptimal response to induction chemotherapy: a randomized phase 2 trial. (PubMed, Nat Commun)
    These findings indicate that adding nimotuzumab to CCRT does not improve survival in patients with LA-NPC with a suboptimal response to IC, underscoring the need for predictive biomarkers and alternative therapeutic strategies. Trial registration: NCT04223024.
    P2 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    TheraCIM (nimotuzumab)
    2ms
    Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC (clinicaltrials.gov)
    P2, N=46, Recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    carboplatin • albumin-bound paclitaxel • Hetronifly (serplulimab) • TheraCIM (nimotuzumab)
    3ms
    Efficacy of Tunlametinib in Combination With Anti-EGFR Monoclonal Antibody in Patients With RAS-Mutated Advanced Gastrointestinal Malignancies (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Chinese PLA General Hospital
    New P2 trial
    |
    RAS mutation
    |
    Erbitux (cetuximab) • Kolupin (tunlametinib) • TheraCIM (nimotuzumab)
    3ms
    Postoperative Radiotherapy Combined With Nimotuzumab Followed by Bemcentinib in High-Risk Patients With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=370, Not yet recruiting, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    cisplatin • bemcentinib (BGB324) • TheraCIM (nimotuzumab)