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    DRUG:

    Andewei (benmelstobart)

    i
    Other names: APL-502, CBT 502, TQB2450, CBT-502, TQ-B2450, APL 502, APL502, CBT502, TQB 2450
    Company:
    Apollomics, Sino Biopharm
    Drug class:
    PD-L1 inhibitor
    Related drugs:
    6d
    ALTER-UC-011: Anlotinib + Benmelstobart vs Surgery for Patients With Localized Renal Cell Carcinoma Scheduled to Undergo Partial Nephrectomy (clinicaltrials.gov)
    P2, N=144, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    Focus V (anlotinib) • Andewei (benmelstobart)
    13d
    FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov)
    P2, N=716, Recruiting, Fudan University | Trial completion date: Sep 2028 --> Sep 2029 | Trial primary completion date: Dec 2026 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • FOXC1 (Forkhead Box C1)
    |
    Herceptin (trastuzumab) • carboplatin • Focus V (anlotinib) • Perjeta (pertuzumab) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Irene (pyrotinib) • albumin-bound paclitaxel • cyclophosphamide • letrozole • epirubicin • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • Andewei (benmelstobart) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • Idafang (ivonescimab) • bulumtatug fuvedotin (9MW2821) • AiRuiLi (adebrelimab) • IBI-354 • SHR-4602 • TQB2102 • TQB2868 • anbenitamab repodatecan (JSKN003) • tizetatug rezetecan (SHR-A1921)
    19d
    Neoadjuvant PD-L1 Inhibitor Plus Anlotinib for Kidney Preservation in Complex Renal Cell Carcinoma (clinicaltrials.gov)
    P2, N=33, Not yet recruiting, RenJi Hospital
    New P2 trial
    |
    Focus V (anlotinib) • Andewei (benmelstobart)
    1m
    Carboplatin/Cisplatin + Etoposide + Benmelstobart Sequential Benmelstobart Combined With Anlotinib Versus Carboplatin/Cisplatin + Etoposide + Tislelizumab Sequential Tislelizumab in the Treatment of Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=40, Terminated, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=134 --> 40 | Trial completion date: Apr 2027 --> Apr 2026 | Recruiting --> Terminated | Trial primary completion date: Oct 2026 --> Apr 2026; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    cisplatin • carboplatin • Focus V (anlotinib) • Tevimbra (tislelizumab-jsgr) • etoposide IV • Andewei (benmelstobart) • bemarituzumab (AMG 552)
    2ms
    Clinical Trials of Benmelstobart Injection Combined With Anlotinib Hydrochloride Capsules in the Treatment of Advanced or Unresectable Alveolar Soft Part Sarcoma (clinicaltrials.gov)
    P2, N=33, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • IL2 (Interleukin 2)
    |
    Focus V (anlotinib) • Andewei (benmelstobart)
    2ms
    Benmelstobart Plus TPF Chemotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase 2 Trial (ChiCTR2600119884)
    P2, N=36, Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    New P2 trial
    |
    cisplatin • docetaxel • 5-fluorouracil • Andewei (benmelstobart)
    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
    Benmelstobart Plus Anlotinib Combined With SBRT for Patients With Hepatocellular Carcinoma Failing First-Line Targeted Therapy (clinicaltrials.gov)
    P2, N=29, Not yet recruiting, Nanfang Hospital, Southern Medical University
    New P2 trial
    |
    Focus V (anlotinib) • Andewei (benmelstobart)
    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)
    2ms
    A Single-arm, Multicenter Exploratory Clinical Trial of Anlotinib Combined With TQB2450 and the SOX Regimen as First-line Treatment for Advanced Gastric Cancer With Low PD-L1 Expression (clinicaltrials.gov)
    P2, N=37, Active, not recruiting, Yongxu Jia | Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2025 --> Jun 2026
    Enrollment closed • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative
    |
    Focus V (anlotinib) • oxaliplatin • Andewei (benmelstobart) • Teysuno (gimeracil/oteracil/tegafur)
    2ms
    A Phase II Study of Benmelstobart + Anlotinib + Chemotherapy as First-Line Treatment for LCNEC and EP-NEC (clinicaltrials.gov)
    P2, N=48, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    cisplatin • carboplatin • Focus V (anlotinib) • etoposide IV • Andewei (benmelstobart)
    2ms
    Advanced pancreatic ductal adenocarcinoma with liver metastases treated with multimodal therapy: a case report. (PubMed, Front Oncol)
    The patient underwent multimodal comprehensive treatment, including iodine-125 seed implantation at the pancreatic primary site, eight cycles of hepatic arterial infusion chemotherapy, PD-L1 inhibitor (Benmelstobart), and oral S-1 maintenance therapy. After treatment, the patient's liver metastases significantly decreased in size (partial response according to RECIST 1.1), CA19-9 levels dropped from 4141.57 U/mL to 58.64 U/mL, overall survival exceeded 15 months, and quality of life remained good (ECOG score 1). The MDT strategy, particularly the combination of local interventional therapy with systemic treatment and immunotherapy, can effectively control both the primary and metastatic lesions of advanced PDAC, significantly prolonging patient survival and providing valuable treatment references for similar cases.
    Journal
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    Andewei (benmelstobart)