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Patients and methods: 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). 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. 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 … 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. 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. National Library of Medicine Background: Physiologically, the tight junction protein CLDN18.2 is present only in the gastric mucosa. CLDN18.2 is a tumour-specific marker in gastric or gastro-oesophageal junction cancers. Trastuzumab for the treatment of HER2-positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. Upon malignant transformation, CLDN18.2 epitopes are exposed on the cell surface and accessible to targeted therapy. 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. IMAB362 was developed by Ganymed Pharmaceuticals AG. 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. IMAB362 targets a protein called CLDN18.2, which is commonly found on tumor cells of stomach and/or GEJ cancers. 2017 Aug 29;8(8):CD004064. Median PFS was 102 days. Each phase has a different goal that helps researchers answer specific questions. AA and JP report employment from Astellas. • IMAB362, an anti-CLDN18.2 mAb, mediates tumour cell death through ADCC and CDC. All other authors have declared no conflicts of interest. 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. Characterization of zolbetuximab in pancreatic cancer models. 2021 Feb 19;S0923-7534(21)00122-8. doi: 10.1016/j.annonc.2021.02.005. ...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. 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 A monoclonal antibody, zolbetuximab (formerly known as IMAB362), has been generated against CLDN18.2. For people ages 16 and 17, a parent or guardian must call their doctor’s office. 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). In Phase 3, the goal is to test the medicine compared to different treatments. The drug is in phase II clinical trials as of January 2013. Zolbetuximab, a chimeric monoclonal antibody, mediates specific killing of CLDN18.2-positive cells through immune effector mechanisms. 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 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). 8600 Rockville Pike • Single-dose IMAB362 at doses of 33–1000 mg/m 2 was generally well tolerated. 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. 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. 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. BM reports honoraria from Angelini Pharma, Astellas, Bayer, BMS, Eliamm, Merck Serono, MSD, Novartis, Pfizer, Roche, and Sanofi. Patients must recover from the serious side effects of prior therapies before entering the study. As an example, patients must be well enough that they would be able to carry out office work or light housework. 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. Privacy, Help In a phase 2 clinical trial (FAST: NCT01630083 ), zolbetuximab in conjunction with chemotherapy prolonged overall and progression-free survival over … 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. This study will also evaluate other anti-tumor effects, tumor markers and pharmacokinetics (PK) of zolbetuximab, Nab-P and GEM. Arm 3 (exploratory) was added after enrolment initiation (zolbetuximab + EOX 1000 mg/m2 Q3W, n = 85). 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. Early evidence for antitumoral activity was observed in the phase II trial. 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). IMAB362 is a first-in-class monoclonal antibody targeting the cell surface molecule Claudin18.2. doi: 10.1080/2162402X.2018.1523096. doi: 10.1002/14651858.CD004064.pub4. 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. Would you like email updates of new search results? 16. Results: Zolbetuximab + EOX was generally tolerated and AEs were manageable. The median survival of people using the treatment plus … 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, … In the phase II study, median OS was 13.2 versus 8.4 months, with IMAB362 and without, respectively (HR, 0.51;P= .0001). Health Technol Assess. IMAB362 is a monoclonal antibody specific for the tight junction protein Claudin 18.2 (CLDN18.2). 2018 Nov 10;8(1):e1523096. Eligible patients over 18 can use this link to schedule a vaccination. Therefore, claudin 18.2 is a promising target for immunotherapy. 2019 Sep 1;30(9):1487-1495. doi: 10.1093/annonc/mdz199. 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. 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) For the Astellas criteria on data sharing see: https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Astellas.aspx. eCollection 2019. Careers. The phase 2 clinical trial, involving 161 patients, focused on an antibody called IMAB362. The treatments in this study are given intravenously (by vein). 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 normal tissue, CLDN18.2 is exclusively expressed in the gastric mucosa. IMAB362 extended progression-free and overall survival by 3.1 months and 4.8 months, respectively. Copyright © 2021. Nakamura Y, Kawazoe A, Lordick F, Janjigian YY, Shitara K. Nat Rev Clin Oncol. IMAB362.....A Phase IIb trial is evaluating IMAB362 plus chemotherapy as first-line treatment of gastroesophageal cancer. Online ahead of print. Clinical trial information: NCT01197885. 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. Chemotherapy for advanced gastric cancer. The primary endpoint was progression-free survival (PFS) and overall survival (OS) was a secondary endpoint. In the phase II study, median OS was 13.2 versus 8.4 months, with IMAB362 and without, respectively (HR, 0.51; P = .0001). Conclusions: 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 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. Please enable it to take advantage of the complete set of features! For additional information, Read more. Subsequently, a phase IIb (FAST) study evaluated clau-diximab as first line in patients with advanced/recurrent gastric and GEJ cancer. Keywords: 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. Clipboard, Search History, and several other advanced features are temporarily unavailable. References Patients in this study will receive IMAB362 alone or in combination with mFOLFOX6. 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. 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 … Background: Conclusions: IMAB362 antibody therapy of patients with advanced CLDN18.2-positive gastroesophageal adenocarcinomas is safe and well tolerated. 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. This site needs JavaScript to work properly. advanced gastric cancer; advanced gastroesophageal junction adenocarcinoma; advanced oesophageal adenocarcinoma; capecitabine (EOX); claudin 18.2; epirubicin; oxaliplatin; zolbetuximab. Patients must have inoperable or metastatic gastric or GEJ cancer that is positive for the CLDN18.2 protein. Further clinical evaluation of IMAB362 in patients with CLDN18.2 tumors is warranted. 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. 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 Background. COVID-19 is an emerging, rapidly evolving situation. 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. 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 …

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