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    DRUG:

    bemarituzumab (AMG 552)

    i
    Other names: AMG-552, AMG 552, FPA144, FPA 144, FPA-144, AMG552
    Company:
    Amgen, ZAI Lab
    Drug class:
    FGFR2b inhibitor
    Related drugs:
    13d
    BEMAFLOT: Study Evaluating the Combination of Bemarituzumab + FLOT Chemotherapy in Perioperative Setting for Resectable Stage cT2-T4a or N+ Gastric and GEJ Adenocarcinoma Overexpressing FGFR2b (clinicaltrials.gov)
    P2, N=0, Withdrawn, Institut Cancerologie de l'Ouest | N=49 --> 0 | Trial completion date: Jun 2034 --> Jan 2026 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jun 2029 --> Jan 2026
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date
    |
    FGFR2 overexpression
    |
    docetaxel • oxaliplatin • bemarituzumab (AMG 552)
    27d
    Bemarituzumab in FGFR2b+ Patients With Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction, Who Failed at Least One Prior Line of Palliative Chemotherapy (clinicaltrials.gov)
    P2, N=126, Active, not recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    paclitaxel • Cyramza (ramucirumab) • irinotecan • Lonsurf (trifluridine/tipiracil) • bemarituzumab (AMG 552)
    2ms
    FORTITUDE-102: Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer. (clinicaltrials.gov)
    P3, N=515, Active, not recruiting, Amgen | Trial primary completion date: Jan 2026 --> Oct 2025
    Trial primary completion date
    |
    FGFR2 (Fibroblast growth factor receptor 2)
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • bemarituzumab (AMG 552)
    2ms
    FORTITUDE-103: A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer. (clinicaltrials.gov)
    P1/2, N=72, Active, not recruiting, Amgen | Trial completion date: Mar 2028 --> Aug 2026
    Trial completion date
    |
    FGFR2 overexpression
    |
    Opdivo (nivolumab) • capecitabine • oxaliplatin • bemarituzumab (AMG 552)
    3ms
    Precision Antibody Therapy in Gastric and Gastroesophageal Cancer: Targeting FGFR2b, CLDN18.2, and VEGFR2. (PubMed, Cells)
    This review examines the mechanisms, safety profiles, and clinical trial outcomes of three targeted agents-bemarituzumab, zolbetuximab, and ramucirumab-which inhibit tumor growth through the FGFR2b, CLDN18.2, and VEGFR2 pathways, respectively. We also compare traditional versus adaptive clinical trial designs, explore emerging challenges such as therapeutic resistance and treatment-related toxicities, and consider implications for personalized medicine. Collectively, these agents represent a paradigm shift from empiric chemotherapy toward biomarker-driven immunotherapy, with the potential to significantly improve survival and quality of life in patients with advanced G/GEJ cancers.
    Review • Journal • IO biomarker
    |
    CLDN18 (Claudin 18) • KDR (Kinase insert domain receptor)
    |
    Cyramza (ramucirumab) • Vyloy (zolbetuximab-clzb) • bemarituzumab (AMG 552)
    3ms
    A single-arm, exploratory, phase II clinical trial of bemarituzumab combined with anlotinib, etoposide and carboplatin followed by thoracic radiotherapy as first-line treatment for extensive-stage small cell lung cancer. (ChiCTR2500110390)
    P2, N=39, Not yet recruiting, Affiliated Hospital of Guangdong Medical University; Affiliated Hospital of Guangdong Medical University
    New P2 trial
    |
    carboplatin • Focus V (anlotinib) • etoposide IV • bemarituzumab (AMG 552)
    4ms
    FORTITUDE-103: A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer. (clinicaltrials.gov)
    P1/2, N=72, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting | Trial completion date: Aug 2028 --> Mar 2028 | Trial primary completion date: Jun 2026 --> Jan 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    FGFR2 overexpression
    |
    Opdivo (nivolumab) • capecitabine • oxaliplatin • bemarituzumab (AMG 552)
    5ms
    ANGELICA: AssociatiNG Bevacizumab bEmarituzumab for GynecoLogIcal CAncer (clinicaltrials.gov)
    P1/2, N=87, Not yet recruiting, Centre Leon Berard
    New P1/2 trial
    |
    Avastin (bevacizumab) • bemarituzumab (AMG 552)
    6ms
    A Phase II Clinical Trial Evaluating the Efficacy and Safety of Bemarituzumab in Combination with Anlotinib as Consolidation Therapy in Limited-Stage Small Cell Lung Cancer (LS-SCLC) Patients Without Progression After Definitive Treatment (L-STAR Study) (ChiCTR2500106624)
    P2, N=35, Not yet recruiting, Shandong First Medical University Affiliated Cancer Hospital; Shandong First Medical University Affiliated Cancer Hospital
    New P2 trial
    |
    Focus V (anlotinib) • bemarituzumab (AMG 552)
    6ms
    FORTITUDE-301: A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (clinicaltrials.gov)
    P1/2, N=260, Active, not recruiting, Amgen | Trial completion date: Sep 2027 --> Feb 2026
    Trial completion date • Pan tumor
    |
    bemarituzumab (AMG 552)
    6ms
    FORTITUDE-101: Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (clinicaltrials.gov)
    P3, N=547, Active, not recruiting, Amgen | Trial completion date: Aug 2025 --> Jun 2026
    Trial completion date
    |
    FGFR2 (Fibroblast growth factor receptor 2)
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • bemarituzumab (AMG 552)
    6ms
    FORTITUDE-103: A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer. (clinicaltrials.gov)
    P1/2, N=70, Recruiting, Amgen | Trial completion date: Apr 2028 --> Aug 2028 | Trial primary completion date: Mar 2026 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • capecitabine • oxaliplatin • bemarituzumab (AMG 552)