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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:
    7d
    HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients (clinicaltrials.gov)
    P2, N=133, Recruiting, Zhejiang University | N=32 --> 133
    Enrollment change
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    gemcitabine • albumin-bound paclitaxel • TheraCIM (nimotuzumab) • HRS-4642
    13d
    HRS-4642 Combined With Nimotuzumab in the Treatment of Recurrent or Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=20, Active, not recruiting, West China Hospital | Trial primary completion date: Jan 2027 --> Aug 2026 | Recruiting --> Active, not recruiting
    Enrollment closed • Trial primary completion date
    |
    TheraCIM (nimotuzumab) • HRS-4642
    14d
    Pancreatic Ductal Adenocarcinoma with ITSN1-ALK Fusion: Sustained Response to Alectinib with 19-Month Progression-Free Survival. (PubMed, Oncologist)
    Oncologists should consider broad next-generation sequencing, including fusion detection, for patients with KRAS-wildtype PDAC. When an ALK fusion is identified, ALK inhibitor therapy can yield durable disease control.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • CA 19-9 (Cancer antigen 19-9)
    |
    TP53 mutation • ALK positive • KRAS wild-type • ALK fusion • RAS wild-type
    |
    gemcitabine • Alecensa (alectinib) • Lorbrena (lorlatinib) • capecitabine • albumin-bound paclitaxel • TheraCIM (nimotuzumab)
    19d
    Nimotuzumab Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=182, Recruiting, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • docetaxel • Tevimbra (tislelizumab-jsgr) • albumin-bound paclitaxel • TheraCIM (nimotuzumab)
    22d
    Efficacy and safety of targeted therapies for glioblastoma: a systematic review and network meta-analysis. (PubMed, BMC Cancer)
    Bevacizumab was associated with improved PFS, but not OS compared to standard therapy and other targeted therapies in newly diagnosed GBM patients. Exploratory subgroup findings suggested that nivolumab may be associated with less favorable OS and PFS estimates in MGMT-unmethylated patients. SUCRA rankings should be interpreted as exploratory because most interventions were supported by limited trial evidence. However, certain targeted drugs exhibit inadequate safety profiles, and careful risk-benefit assessment is required. Future research should further explore safer and more effective multi-targeted combination strategies to overcome GBM's survival bottleneck.
    Retrospective data • Journal
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • temozolomide • Recentin (cediranib) • TheraCIM (nimotuzumab) • depatuxizumab mafodotin (ABT-414) • marizomib (NPI-0052)
    24d
    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)
    2ms
    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) • eribulin mesylate • TheraCIM (nimotuzumab)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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)