Of these, 54 patients were eligible and four received 300 mg/m 2 zolbetuximab in cohort 1, and 50 received 600 mg/m 2 zolbetuximab in cohorts 2 and 3. Advertisers, Journal of Clinical Oncology Cancer.Net, ASCO.org The website cannot function properly without these cookies, and can only be disabled by changing your browser preferences. Secondary endpoints are overall survival; objective response rate; duration of response; and the safety/tolerability, pharmacokinetics, and immunogenicity of zolbetuximab. *3 *1 World Health Organization Cancer Fact Sheet 2018. Details 15_suppl, Newest Articles D.H. Ilson: Advisory/Consultancy: Astellas Pharma. JCO Oncology Practice Domenica Lorusso. ASCO Author Services Phase II. MINIMAL Requirements: Google Chrome 24+, Mozilla Firefox 20+, Internet Explorer 11, Opera 15–18, Apple Safari 7, SeaMonkey 2.15-2.23. A. Arozullah: Full/Part-time employment: Astellas Pharma. Patients were randomized to ZOL/EOX or EOX alone. A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Close Weill Cornell Medical College, New York, NY; The University of Texas - MD Anderson Cancer Center, Houston, TX; Institut für Klinisch-Onkologische Forschung, Frankfurt, Germany; Seoul National University College of Medicine, Seoul, South Korea; Gastrointestinal Oncology Program, The University of Chicago, Chicago, IL; Dana-Farber Cancer Institute, Boston, MA; Memorial Sloan Kettering Cancer Center, New York, NY; University of Colorado Comprehensive Cancer Center, Aurora, CO; University Cancer Center Leipzig, Leipzig, Germany; National Cancer Center Hospital East, Kashiwa, Japan; University Hospitals Gasthuisberg Leuven, KU Leuven, Leuven, Belgium; Astellas Pharma Global Development, Inc., Northbrook, IL; Sun Yat-sen University Cancer Centre, Guangzhou, China, Professional English and Academic Editing Support, https://doi.org/10.1200/JCO.2020.38.15_suppl.TPS4648, Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline, Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: ASCO Clinical Practice Guideline Update, Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2−, Node-Positive, High-Risk, Early Breast Cancer (monarchE), Prognostic Index for Acute- and Lymphoma-Type Adult T-Cell Leukemia/Lymphoma, Updated Analysis From KEYNOTE-189: Pembrolizumab or Placebo Plus Pemetrexed and Platinum for Previously Untreated Metastatic Nonsquamous Non–Small-Cell Lung Cancer, Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update, Patient-Clinician Communication: American Society of Clinical Oncology Consensus Guideline, Updating the American Society of Clinical Oncology Value Framework: Revisions and Reflections in Response to Comments Received, American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options, Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial, 2318 Mill Road, Suite 800, Alexandria, VA 22314, © 2021 American Society of Clinical Oncology. DOI: 10.1200/JCO.2020.38.15_suppl.TPS4648 Journal of Clinical Oncology
CancerLinQ Zolbetuximab (zolbe), a chimeric IgG1 monoclonal antibody, binds to CLDN18.2 and mediates cell death through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. Claudin (CLDN)18.2, a tight junction protein and new molecular target, is confined to gastric mucosa (ie, cells in the pit and base regions of the gastric glands) in healthy tissue. Claudin (CLDN)18.2 has emerged as a promising targetable biomarker. Patients are required to have CLDN18.2+/HER2− locally advanced unresectable or metastatic G or GEJ adenocarcinoma that is radiographically evaluable per RECIST v1.1. A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2 Positive, HER2-Negative, Metastatic … Capecitabine + oxaliplatin (CAPOX) is a standard first-line treatment for advanced gastric cancer. As of June 30, 2020, 190 sites have been initiated. Enzinger: Advisory/Consultancy: Merck; Advisory/Consultancy: Astellas; Advisory/Consultancy: Celgene; Advisory/Consultancy: Lilly; Advisory/Consultancy: Loxo; Advisory/Consultancy: Taiho; Advisory/Consultancy: Zymeworks. Methods: This phase 3, double-blind, placebo-controlled study (NCT03653507) will enroll ~500 adult patients from global sites. Contact Us For more detailed information on the cookies we use, please check our Privacy Policy. Brief Title: A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer Official Title: A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo … J.W. STORM was a multicenter, open-label, single arm trial evaluating selinexor … Norikazu Masuda, Session: Zolbetuximab has been investigated in 4 clinical trials, of which 4 are open and 0 are closed. Presenter: Prior chemotherapy for advanced/metastatic G/GEJ is not permitted. Pancreatic adenocarcinoma. A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Eligibility Currently, two phase III trials are ongoing to test the 1L use of zolbetuximab in combination with mFOLFOX6 (SPOTLIGHT: NCT03504397) or CAPOX (GLOW: NCT03653507). Archive S. Kim: Travel/Accommodation/Expenses: Astellas Pharma. Upon malignant transformation, structural loss in G/GEJ cells may allow antibodies more access to previously unavailable CLDN18.2. May 25, 2020. ClinicalTrials.gov. Methods: This phase 3, double-blind, ... (0 to 2 vs ≥3), and prior gastrectomy (yes vs no). This global, phase III, double-blind, placebo-controlled study (NCT03653507) will enroll ∼500 adult pts with CLDN18.2+/HER2– locally advanced unresectable or metastatic GC or GEJ not previously treated with chemotherapy for advanced/metastatic disease. A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma A multicentre, phase IIa study of zolbetuximab as a single agent in patients with recurrent or refractory advanced adenocarcinoma of the stomach or lower oesophagus: the MONO study Ann Oncol. Details A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer Park: Full/Part-time employment: Astellas Pharma. Other secondary endpoints: objective response rate; duration of response; safety/tolerability, pharmacokinetics, and immunogenicity of zolbe. Why is this study being done? is primarily based on Part 2 of the phase 2b trial, KCP-330-012 (STORM). Randomization will be stratified by region (Asia vs non-Asia), number of metastatic sites (0 to 2 vs ≥3), and prior gastrectomy (yes vs no). A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer - NCT03504397 Eligible pts should have locally advanced unresectable or metastatic G/GEJ that is CLDN18.2+/human epidermal growth factor receptor 2-negative (HER2–) and radiologically evaluable lesions per RECIST v1.1. Patients will receive zolbe 800 mg/m2 IV on Cycle 1 Day 1 (loading dose), then 600 mg/m2 IV every 3 weeks; mFOLFOX6 will be administered on Days 1, 15, and 29 of each 42-day cycle (4 cycles). Background: Gastric cancer is the fourth leading cause of cancer death worldwide. e-Poster Display Session, Presenter: 10.1016/annonc/annonc356, SPOTLIGHT: Phase III study of zolbetuximab + mFOLFOX6 versus placebo + mFOLFOX6 in first-line Claudin18.2⁺/HER2⁻ advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (G/GEJ), HER2CLIMB-02: A randomized, double-blind, phase III study of tucatinib or placebo with T-DM1 for unresectable locally-advanced or metastatic HER2+ breast cancer, KEYLYNK-009: A phase II/III, open-label, randomized study of pembrolizumab (pembro) + olaparib (ola) vs pembro + chemotherapy after induction with first-line (1L) pembro + chemo in patients (pts) with locally recurrent inoperable or metastatic TNBC, MADELINE Asia: A mobile app-based prospective observational study of patient reported outcomes in advanced breast cancer in Asia, Prospective observational study monitoring circulating tumour DNA in resectable colorectal cancer patients undergoing radical surgery: GALAXY study in CIRCULATE-Japan, GLOW: Phase III study of first-line zolbetuximab + CAPOX versus placebo + CAPOX in Claudin18.2⁺/HER2⁻ advanced/metastatic gastric or gastroesophageal junction adenocarcinoma (G/GEJ), Perioperative sintilimab in combination with concurrent chemoradiotherapy for patients with locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma, A randomized, double-blind, phase III study of pembrolizumab plus chemotherapy as first-line therapy in patients with HER2-negative, advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: KEYNOTE-859, Pembrolizumab (pembro) or placebo added to docetaxel and prednisone/prednisolone for metastatic castration-resistant prostate cancer (mCRPC) previously treated with next-generation hormonal agents (NHAs): KEYNOTE-921 phase III study, ENGOT-cx11/KEYNOTE-A18: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab With Chemoradiotherapy in Patients With High-Risk Locally Advanced Cervical Cancer, LAURA: Osimertinib maintenance following definitive chemoradiation therapy (CRT) in patients (pts) with unresectable stage III epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC), Interpreting Oncological Study Publications, Cancer Diagnosis and Treatment Evaluation, Rehabilitation Issues During Cancer Treatment and Follow-Up, Cancer Treatment in Special Clinical Situations, Clinical Pharmacology of Anti-Cancer Agents, ESMO Members: Build Your Own ESMO Library, International Prognostic Index Tools for Lymphoma, Anti-Cancer Agents and Biological Therapy, Drug-Drug Interactions with Kinase Inhibitors, PARP inhibition and DNA Damage Response (DDR), Cancer Aetiology, Epidemiology and Prevention, Cancer in Special situations (pregnancy, young, elderly, hereditary...), Multikinase Inhibitor-Related Skin Toxicity, Precision Medicine and Validated Biomarkers, ESMO Recommendations in Precision Medicine, Translational Research: Biomarkers & Diagnostics.
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