Background. For additional information, Read more. Keywords: Subsequently, a phase IIb (FAST) study evaluated clau-diximab as first line in patients with advanced/recurrent gastric and GEJ cancer. Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. The single-arm MONO trial (NCT01197885) assessed IMAB362 (600 mg/m 2) monotherapy as salvage therapy in GA/GEJA patients and showed a 30% disease control rate.The FAST trial (NCT01630083) assessed IMAB362 (loading dose 800 mg/m 2 then 600 mg/m 2) combination therapy as 1st line therapy (IMAB362+EOX followed by single agent IMAB362 maintenance until … Patients with CLDN18.2 expression of ≥2+ in ≥40% tumor cells (as validated by CLAUDE-TECT™ 18.2 Kit), Eastern Cooperative Oncology Group Table 1 Various clinical trials involving claudiximab (IMAB362) Patients received first-line epirubicin + oxaliplatin + capecitabine (EOX, arm 1, n = 84) every 3 weeks (Q3W), or zolbetuximab + EOX (loading dose, 800 mg/m2 then 600 mg/m2 Q3W) (arm 2, n = 77). Therefore, claudin 18.2 is a promising target for immunotherapy. 826 - Claudin 18.2 – a novel treatment target in the multicenter, randomized, phase II FAST study, a trial of epirubicin, oxaliplatin, and capecitabine (EOX) with or without the anti-CLDN18.2 antibody IMAB362 as 1st line therapy in advanced gastric and gastroesophageal junction (GEJ) cancer Researchers think that giving IMAB362 alone or in combination with mFOLFOX6 will help target the chemotherapy to selectively attack cancer cells, and slow or prevent the growth of cancer. The primary endpoint was progression-free survival (PFS) and overall survival (OS) was a secondary endpoint. KW reports honoraria from Ganymed Pharmaceuticals. IMAB362 was developed by Ganymed Pharmaceuticals AG. The purpose of this study is to evaluate the safety and effectiveness of the investigational drug IMAB362 when given alone or in combination with standard mFOLFOX6 chemotherapy (leucovorin calcium, fluorouracil, and oxaliplatin) in patients with inoperable or metastatic stomach cancer or cancer of the gastroesophageal junction (GEJ). IMAB362 is a monoclonal antibody specific for the tight junction protein Claudin 18.2 (CLDN18.2). Wagner AD, Syn NL, Moehler M, Grothe W, Yong WP, Tai BC, Ho J, Unverzagt S. Cochrane Database Syst Rev. Claudin 18.2 (CLDN18.2) is contained within normal gastric mucosa epithelial tight junctions; upon malignant transformation, CLDN18.2 epitopes become exposed. A Randomized Phase II Multicenter, Open-Label Study Evaluating the Efficacy and Safety of IMAB362 in Combination With the EOX (Epirubicin, Oxaliplatin, Capecitabine) Regimen as First-Line Treatment of Patients With CLDN18.2-Positive Advanced Adenocarcinomas of the Stomach, the Esophagus or the Gastroesophageal Junction In the overall population, both PFS [hazard ratio (HR) = 0.44; 95% confidence interval (CI), 0.29-0.67; P < 0.0005] and OS (HR = 0.55; 95% CI, 0.39-0.77; P < 0.0005) were significantly improved with zolbetuximab + EOX (arm 2) compared with EOX alone (arm 1). From radiation therapy to clinical trials to check-ins with your doctor, your care is made as convenient as possible. CLDN18.2 is a tumour-specific marker in gastric or gastro-oesophageal junction cancers. Please enable it to take advantage of the complete set of features! The magnitude of response seen with IMAB362 was proportional to the expression level of CLDN18.2, which is a splice variant of the claudin-18 protein. Privacy, Help MSK is offering COVID-19 vaccines to our patients 16 and over, who live, work or study in New York State. Safety/tolerability, including determination of maximum tolerated dose and recommended phase II dose, were the primary objectives; secondary objectives included assessment of the IMAB362 pharmacokinetic profile, immunogenicity, and antitumour activity (assessed by … Data sharing Researchers may request access to anonymised participant level data, trial level data, and protocols from Astellas sponsored clinical trials at www.clinicalstudydatarequest.com. This significant PFS benefit was retained in patients with moderate-to-strong CLDN18.2 expression in ≥70% of tumour cells (HR = 0.38; 95% CI, 0.23-0.62; P < 0.0005). 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 Unr Accessibility Published by Elsevier Ltd. Disclosure US reports co-founder and shareholder at Ganymed and also holds several patents, with royalties paid by Astellas; founder, chief executive officer, and shareholder of BioNTech. Chemotherapy for advanced gastric cancer. The aim of this phase II study is to establish efficacy and safety of multiple doses of IMAB362 as monotherapy in patients suffering from metastatic, refractory or recurrent adenocarcinoma of the stomach or the lower esophagus. National Library of Medicine This study will also evaluate other anti-tumor effects, tumor markers and pharmacokinetics (PK) of zolbetuximab, Nab-P and GEM. In advanced gastric/gastro-oesophageal junction and oesophageal adenocarcinoma patients expressing CLDN18.2, adding zolbetuximab to first-line EOX provided longer PFS and OS versus EOX alone. Online ahead of print. Zolbetuximab + EOX was generally tolerated and AEs were manageable. 2017 Aug 29;8(8):CD004064. Biomarker-targeted therapies for advanced-stage gastric and gastro-oesophageal junction cancers: an emerging paradigm. COVID-19 Vaccine Available to MSK Patients, A Phase II Study of IMAB362 in Patients with Advanced Inoperable Stomach Cancer. The purpose of this study is to confirm the recommended phase 2 dose (RP2D) of zolbetuximab in combination with Nab-P + GEM, determine overall survival and assess the safety and tolerability of the combination treatment. Background: Physiologically, the tight junction protein CLDN18.2 is present only in the gastric mucosa. Each phase has a different goal that helps researchers answer specific questions. Patients and methods: Early evidence for antitumoral activity was observed in the phase II trial. FAST: A randomised phase II study of zolbetuximab (IMAB362) plus EOX vs EOX alone for first-line treatment of advanced CLDN18.2 positive gastric and gastro-oesophageal adenocarcinoma IMAB362 nearly doubles survival in patients with the highest levels of Claudin18.2 target MAINZ, Germany, June 5, 2016 /PRNewswire/ -- Ganymed Pharmaceuticals AG, a biopharmaceutical company developing highly targeted immunotherapies against cancer, announced outstanding data from its randomized Phase II clinical study of IMAB362 in first-line treatment of gastric cancer at the ASCO … Clinical trial information: NCT01197885. 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 Türeci O, Sahin U, Schulze-Bergkamen H, Zvirbule Z, Lordick F, Koeberle D, Thuss-Patience P, Ettrich T, Arnold D, Bassermann F, Al-Batran SE, Wiechen K, Dhaene K, Maurus D, Gold M, Huber C, Krivoshik A, Arozullah A, Park JW, Schuler M. Ann Oncol. For the Astellas criteria on data sharing see: https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Astellas.aspx. Background: eCollection 2019. However, following malignant transformation, gastric cancer metastases maintain this expression. 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 … 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. References MS reports consultant fees from AstraZeneca, Boehringer Ingelheim, BMS, Novartis, Roche, and Takeda; honoraria from Abbvie, Boehringer Ingelheim, BMS, MSD, Novartis, and Pierre Fabre; research funding from AstraZeneca, Boehringer Ingelheim, BMS, and Novartis, and patents with the University Duisburg-Essen. IMAB362 is a first-in-class monoclonal antibody targeting the cell surface molecule Claudin18.2. Arm 3 (exploratory) was added after enrolment initiation (zolbetuximab + EOX 1000 mg/m2 Q3W, n = 85). Unable to load your collection due to an error, Unable to load your delegates due to an error. Prevention and treatment information (HHS). The median survival of people using the treatment plus … Would you like email updates of new search results? doi: 10.1080/2162402X.2018.1523096. Bethesda, MD 20894, Copyright Characterization of zolbetuximab in pancreatic cancer models. IMAB362 binds to the tight junction protein Claudin-18.2 which is expressed in up to 80% of gastroesophageal adenocarcinomas, 60% of pancreatic tumors as well as in other various solid tumors. FL reports personal fees and/or grants from Astellas, AstraZeneca, Bristol-Myers Squibb (BMS), BioNTech, Lilly, Elsevier, Infomedica, Merck, Merck Sharp & Dohme (MSD), Roche, Servier, and Amgen. In the context of malignant transformation, CLDN18.2 can be found in gastric tumors as well as tumors from organs that do not normally express CLDN18.2 (eg, pancreas). Further clinical evaluation of IMAB362 in patients with CLDN18.2 tumors is warranted. Claudin 18.2 is a tight junction protein that is exclusively expressed in the gastric epithelia. IMAB362 targets a protein called CLDN18.2, which is commonly found on tumor cells of stomach and/or GEJ cancers. All other authors have declared no conflicts of interest. Results: • IMAB362 (300–600 mg/m 2) was determined as suitable for further evaluation. As an example, patients must be well enough that they would be able to carry out office work or light housework. The drug is in phase II clinical trials as of January 2013. CH reports being a co-founder, supervisory board member, and shareholder of Ganymed Pharmaceuticals. IMAB362 reduced the risk of death or progression by approximately 50% when added to standard chemotherapy for patients with CLDN18.2-positive advanced gastric cancers. Norman G, Rice S, Spackman E, Stirk L, Danso-Appiah A, Suh D, Palmer S, Eastwood A. Careers. For people ages 16 and 17, a parent or guardian must call their doctor’s office. Upon malignant transformation, CLDN18.2 epitopes are exposed on the cell surface and accessible to targeted therapy. OT reports founder and chief executive officer of Ganymed until the end of 2016; currently an employee and chief medical officer of BioNTech; patents for the investigational agent, zolbetuximab, with royalties paid by Astellas; consultancy fees from Astellas Pharma. IMAB362.....A Phase IIb trial is evaluating IMAB362 plus chemotherapy as first-line treatment of gastroesophageal cancer. Most adverse events (AEs) related to zolbetuximab + EOX (nausea, vomiting, neutropenia, anaemia) were grade 1-2. Türeci Ӧ, Mitnacht-Kraus R, Wöll S, Yamada T, Sahin U. Oncoimmunology. In the phase II study, median OS was 13.2 versus 8.4 months, with IMAB362 and without, respectively (HR, 0.51; P = .0001). IMAB362 extended progression-free and overall survival by 3.1 months and 4.8 months, respectively. AA and JP report employment from Astellas. The FAST study enrolled advanced gastric/gastro-oesophageal junction and oesophageal adenocarcinoma patients (aged ≥18 years) with moderate-to-strong CLDN18.2 expression in ≥40% tumour cells. To be eligible for this study, patients must meet several criteria, including but not limited to the following: For more information about this study and to inquire about eligibility, please contact Dr. David Ilson at 646-888-4183. Ganymed’s lead program, IMAB362, is in advanced Phase II testing for gastroesophageal cancer. Grade ≥3 AEs showed no substantial increases overall (zolbetuximab + EOX versus EOX alone). 2018 Nov 10;8(1):e1523096. Patient-reported outcomes from the phase II FAST trial of zolbetuximab plus EOX compared to EOX alone as first-line treatment of patients with metastatic CLDN18.2+ gastroesophageal adenocarcinoma. Copyright © 2021. Preliminary results from the phase II 'FAST' trial in June 2016 suggest it is helpful for advanced gastric cancer (and a phase III trial will be planned). Ganymed’s lead program, IMAB362, is in advanced Phase 2 testing for gastroesophageal cancer. Health Technol Assess. In Phase 3, the goal is to test the medicine compared to different treatments. Zolbetuximab (formerly IMAB362) is a chimeric mAb that mediates specific killing of CLDN18.2+ cancer cells through immune effector mechanisms; single-agent activity … Trastuzumab for the treatment of HER2-positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. Clipboard, Search History, and several other advanced features are temporarily unavailable. A Phase 2 Study of Zolbetuximab (IMAB362) as Monotherapy or in Combination with mFOLFOX6 in Subjects with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma whose Tumors have High or Intermediate Claudin (CLDN) 18.2 Expression ...protocol (PP) population of an open-label, European Phase IIa trial showed that 600 mg/m 2 IMAB362.....including 4 partial responses and 6 cases of stable disease. Additionally, being a co-founder, supervisory board member, and shareholder of BioNTech SE, co-founder, advisor and former supervisory board member of TRON, board member to the cutting-edge technology cluster CI3, and president of the international cancer immunotherapy network CIMT. In a phase 2 clinical trial (FAST: NCT01630083 ), zolbetuximab in conjunction with chemotherapy prolonged overall and progression-free survival over … Patients must recover from the serious side effects of prior therapies before entering the study. The treatments in this study are given intravenously (by vein). This site needs JavaScript to work properly. • Single-dose IMAB362 at doses of 33–1000 mg/m 2 was generally well tolerated. 16. © 2021 Memorial Sloan Kettering Cancer Center, Gerstner Sloan Kettering Graduate School of Biomedical Sciences. Conclusions: IMAB362 antibody therapy of patients with advanced CLDN18.2-positive gastroesophageal adenocarcinomas is safe and well tolerated. Nakamura Y, Kawazoe A, Lordick F, Janjigian YY, Shitara K. Nat Rev Clin Oncol. 2021 Mar 23. doi: 10.1007/s10120-020-01153-6. 8600 Rockville Pike Zolbetuximab 800/600 mg/m2 is being evaluated in phase III studies based on clinical benefit observed in the overall population and in patients with moderate-to-strong CLDN18.2 expression in ≥70% of tumour cells. BM reports honoraria from Angelini Pharma, Astellas, Bayer, BMS, Eliamm, Merck Serono, MSD, Novartis, Pfizer, Roche, and Sanofi. Lordick F, Al-Batran SE, Ganguli A, Morlock R, Sahin U, Türeci Ö. Gastric Cancer. In normal tissue, CLDN18.2 is exclusively expressed in the gastric mucosa. COVID-19 is an emerging, rapidly evolving situation. For example, in Phase 2, the goal is to find out if the medicine works and learn more about its safety. 2019 Sep 1;30(9):1487-1495. doi: 10.1093/annonc/mdz199. • IMAB362, an anti-CLDN18.2 mAb, mediates tumour cell death through ADCC and CDC. S-EA reports advisory role from Merck, Roche, Celgene, Lilly, Nordic Pharma, BMS, MSD; speaker role from Roche, Celgene, Lilly, Nordic Pharma, AIO gGmbH, MCI, Promedicis, Forum für Medizinische Fortbildung; CEO/founder of IKF Klinische Krebsforschung GmbH; and clinical trial fees from Sanofi, Merck, Roche, Celgene, Vifor, Medac, Hospira, Lilly, German Cancer Aid (Krebshilfe), and German Research Foundation; and translational research from the Federal Ministry of Education and Research. 2021 Mar 31. doi: 10.1038/s41571-021-00492-2. Results from a randomized phase II study indicate that adding the experimental antibody IMAB362, which targets the tight junction protein claudin18.2, to standard chemotherapy is more effective than chemotherapy alone in previously untreated patients with advanced gastric cancer. FAST: a randomised phase II study of zolbetuximab (IMAB362) plus EOX versus EOX alone for first-line treatment of advanced CLDN18.2-positive gastric and gastro-oesophageal adenocarcinoma Ann Oncol. Median PFS was 102 days. A Phase 2, Open-Label, Randomized Study to Assess the Antitumor Activity and Safety of Zolbetuximab (IMAB362) in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P+GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma In the phase II study, median OS was 13.2 versus 8.4 months, with IMAB362 and without, respectively (HR, 0.51;P= .0001). Zolbetuximab, a chimeric monoclonal antibody, mediates specific killing of CLDN18.2-positive cells through immune effector mechanisms. Background: Claudin 18.2 (CLDN18.2) is physiologically confined to gastric mucosa tight junctions; however, upon malignant transformation, perturbations in cell polarity lead to CLDN18.2 epitopes being exposed on the cancer cell surface. Patients received: IV IMAB362 Q3W, 800 mg/m 2 on Cycle 1, Day 1 and 600 mg/m 2 on Day 1 of every subsequent cycle; IV ZA 4 mg, Day 1 of Cycles 1 and 3; subcutaneous IL-2, Days 1–3 of Cycles 1 and 3. A Phase 2, Open-Label, Randomized Study to Assess the Antitumor Activity and Safety of Zolbetuximab (IMAB362) in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, … Patients must have inoperable or metastatic gastric or GEJ cancer that is positive for the CLDN18.2 protein. advanced gastric cancer; advanced gastroesophageal junction adenocarcinoma; advanced oesophageal adenocarcinoma; capecitabine (EOX); claudin 18.2; epirubicin; oxaliplatin; zolbetuximab. A monoclonal antibody, zolbetuximab (formerly known as IMAB362), has been generated against CLDN18.2. FOIA Conclusions: Patients in this study will receive IMAB362 alone or in combination with mFOLFOX6. Significant improvement in PFS was also reported in the overall population of arm 3 versus arm 1 (HR = 0.58; 95% CI, 0.39-0.85; P = 0.0114) but not in high CLDN18.2-expressing patients; no significant improvement in OS was observed in either population. 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 2021 Feb 19;S0923-7534(21)00122-8. doi: 10.1016/j.annonc.2021.02.005. Eligible patients over 18 can use this link to schedule a vaccination. This study is for patients age 18 and older. 2011 May;15 Suppl 1:33-42. doi: 10.3310/hta15suppl1/04. IMAB362 binds to the tight junction protein Claudin-18.2 which is expressed in up to 80% of gastroesophageal adenocarcinomas, 60% of pancreatic tumors as well as in other various solid tumors. e15079 Background: IMAB362 is the first-in-class monoclonal antibody against the tight junction molecule claudin 18.2 (CLDN18.2) executing its antitumor activity via 4 highly potent modes of action (antibody-dependent cellular cytotoxicity [ADCC], complement-dependent cytotoxicity, proliferation inhibition, apoptosis). Online ahead of print. doi: 10.1002/14651858.CD004064.pub4. The phase 2 clinical trial, involving 161 patients, focused on an antibody called IMAB362.

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