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A study of mirabegron in young children with neurogenic detrusor overactivity

Mirabegron in Young Children Study | Astellas Clinical Trials

A study to learn how [14C]ASP0367 is processed by the body in healthy men

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A Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

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A study to find the best dose of ASP5354 to show lymph nodes in people with breast cancer or melanoma during surgery

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A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

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A study of the safety and tolerability of ASP7317 in adults who are losing their clear, sharp central vision due to geographic atrophy secondary to dry age-related macular degeneration

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A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants with Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

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A Study of an Intratumoral Oncolytic Virus in Patients with Advanced Metastatic Solid Tumors

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A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)

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A study to evaluate ASP0367 in participants with primary mitochondrial myopathy

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A study of ASP2138 in adults with stomach cancer or pancreatic cancer

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A study about how ASP5354 affects the body in healthy adults and in adults whose kidneys do not work well

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A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

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A Study to Assess the Efficacy and Safety of 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

IMAB362 with Nab P and GEM Study for Pancreatic Cancer  | Astellas Clinical Trials

A study of gilteritinib, venetoclax and azacitidine as a combined treatment for people newly diagnosed with acute myeloid leukemia

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A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects with Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

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A study to evaluate ASP0367 in participants with reduced maximum oxygen uptake due to poor systemic oxygen extraction

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A study of ASP3082 in adults with previously treated solid tumors

ASP3082 for Solid Tumors Study | Astellas Clinical Trials

A Study of ASP1570 in adults with locally advanced or metastatic solid tumors

ASP1570 for Advanced or Metastatic Tumors Study | Astellas Clinical Trials

Study of ASP7517 Alone and with Pembrolizumab in Participants with Advanced Solid Tumors Expressing WT1 Antigen

ASP7517 with Pembrolizumab Study | Astellas Clinical Trials

A Safety Surveillance Study in Subjects with Macular Degenerative Disease Treated with Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy

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A study to evaluate mirabegron in pediatric participants from 5 to less than 18 years of age with overactive bladder (OAB)

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Study of ASP0739 Alone and with Pembrolizumab in Advanced Solid Tumors with NY-ESO-1 Expression Participants

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A study of ASP0367 in people with kidneys that do not work well and in healthy people

ASP0367 Study for Adults with Poor Kidneys | Astellas Clinical Trials

Enfortumab vedotin and pembrolizumab vs. chemotherapy alone in untreated locally advanced or metastatic urothelial cancer

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Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under “Sponsor Specific Details for Astellas.”

Redacted CSR Synopsis [English]

PLS_English-GM-IMAB-001.docx

Claudiximab is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. Preclinically, claudiximab was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase I study is to establish safety, toxicity and maximal tolerable dose of a single infusion of claudiximab in patients suffering from relapsing, advanced gastroesophageal and gastric adenocarcinoma

Safety and tolerability study of claudiximab in patients with advanced gastroesophageal cancer

CN CDE Number

EudraCT Number

jRCT Number

NCT ID

Patient Level Data

Product ST Name

Therapeutic Area

Patients receive Claudiximab as intravenous infusion over 2 hours on day 1.
Cohorts of 3-6 patients receive escalating doses of Claudiximab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no dose-limiting toxicity (DLT) is diagnosed in 3 patients or no more than 1 out of 6 patients exhibits a DLT. 
After completion of study treatment, patients are followed for 4 weeks.

Link to results and other applicable study documents on the Astellas Clinical Trials website

Link to plain language summary of the study on the Trial Results Summaries website

Johannes Gutenberg Universität, 1.Med Klinik und Poliklinik

Universitätsklinikum Essen, Innere Klinik (Tumorforschung)

Universität Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT)

Klinikum Rechts-der-Isar, III.Medizinische Klinik und Poliklinik

Pauls Stradins University

Piejuras Hospital

Clinical first-in-human single-dose escalation study evaluating the safety and tolerability of claudiximab (iMAB-362) in hospitalized patients with advanced gastroesophageal cancer. A multi-center, phase I, open-label, i.v. infusion study