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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:
    1d
    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)
    24d
    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)
    30d
    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)
    30d
    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)
    2ms
    HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation (clinicaltrials.gov)
    P2, N=40, Recruiting, Zhejiang University | Not yet recruiting --> Recruiting | Initiation date: Nov 2025 --> Feb 2026
    Enrollment open • Trial initiation date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    paclitaxel • TheraCIM (nimotuzumab) • HRS-4642
    2ms
    Nimotuzumab Combined With Chemoradiotherapy in the Treatment of Unresectable Locally Advanced or Oligometastatic Pancreatic Cancer (clinicaltrials.gov)
    P2, N=30, Enrolling by invitation, Peking University First Hospital
    New P2 trial
    |
    capecitabine • TheraCIM (nimotuzumab)
    2ms
    Adebrelimab Neoadjuvant Treatment for Resectable ESCC (clinicaltrials.gov)
    P=N/A, N=22, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New trial
    |
    cisplatin • albumin-bound paclitaxel • TheraCIM (nimotuzumab) • AiRuiLi (adebrelimab)
    2ms
    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
    2ms
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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)