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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

14C ASP0367 In Males Study | Astellas Clinical Trials

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)

Gilteritnib and Chemotherapy Study | Astellas Clinical Trials

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

ASP5354 to Show Lymph Nodes Study | Astellas Clinical Trials

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

Intravesical Enfortumab Vedotin for Bladder Cancer Study | Astellas Clinical Trials

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

ASP7317 for Geographic Atrophy Study | Astellas Clinical Trials

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

Zolbetuximab Study | Astellas Clinical Trials

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

Intratumoral Oncolytic Virus Study | Astellas Clinical Trials

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

ASP058 Otic Solution Study | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with primary mitochondrial myopathy

ASP0367 Study for Primary Mitochondrial Myopathy | Astellas Clinical Trials

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

ASP2138 Study for Stomach or Pancreatic Cancer | Astellas Clinical Trials

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

ASP5354 for Healthy Adults and Adults with Poor Kidneys | Astellas Clinical Trials

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

Prostate Cancer Study for Previous Participation in Enzalutamide  | Astellas Clinical Trials

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

Gilteritinib Venetoclax and Azacitidine Study for Acute Myeloid Leukemia | Astellas Clinical Trials

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)

ASP7517 for Acute Myeloid Leukimia | Astellas Clinical Trials

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

ASP0367 for Reduced Maxiumum Oxygen Uptake Study | Astellas Clinical Trials

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

Macular Degenerative Disease Study | Astellas Clinical Trials

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

Mirabegron Study in Children with OAB Study | Astellas Clinical Trials

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

ASP0739 with Pembrolizumab Study For Solid Tumors| Astellas Clinical Trials

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

Enfortumab Vedotin and Pembrolizumab vs Chemotherapy Study | Astellas Clinical Trials

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Have questions about or want more information about A Study of LY3471851 in Participants With Gastric Cancer? Contact us by filling out your information below and we’ll respond to you.

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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.”

Participants will receive a loading dose-1 of IMAB362 on Cycle 1 Day 1 followed by a lower dose-2 in subsequent every 3 weeks.

Participants will receive a loading dose-3 of IMAB362 on Day 1 of each cycle (every 3 weeks).

Redacted CSR Synopsis [English]

Plain Language Summary (English)

Plain Language Summary Japanese

Redacted Protocol (Japanese)

The purpose of this study is to assess the safety, tolerability and antitumor activity of IMAB362 in Japanese subjects with locally advanced or metastatic Gastric or GEJ adenocarcinoma whose tumors have Claudin (CLDN) 18.2 Expression. This study will also assess pharmacokinetics and immunogenicity of IMAB362.

A Study of IMAB362 in Japanese Subjects with Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma

This study consists of two parts (Part 1: Safety; and Part 2: Expansion). First, the subjects will be enrolled in Safety Part with IMAB362 dose-1/2 (Arm A). Then the safety and tolerability of Arm A will be evaluated at Tolerability Evaluation Meeting (TEM). If there are no safety and tolerability concerns, enrollment for the Safety Part with IMAB362 dose-3 (Arm B) and the Expansion Part with IMAB362 dose-1/2 will be opened. For each part, participants who continue to derive clinical benefit and do not have intolerable toxicity from study treatment will be allowed to remain on treatment until treatment discontinuation criterion is met.

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Zolbetuximab will be administered as a 2-hour intravenous infusion.

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

Site JP00001

A Phase 1 Open-label Study of IMAB362 in Japanese Subjects with Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma

Any of the IMAB362 related AEs specified as the DLTs will be assessed during the first 3 weeks.

An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) guidelines (Version 4.03).

Number of participants with potentially clinically significant laboratory values will be reported as AEs.

Number of participants with potentially clinically significant body weight change will be reported as AEs.

Number of participants with potentially clinically significant vital sign values will be reported as AEs.

ECGs will be recorded with the participant in the supine position, after the subject has been lying down for approximately 5 minutes. Any clinically significant adverse changes on the ECG will be reported as AEs.

Number of participants with potentially clinically significant ECOG performance status values. ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair and 5 = Dead.

ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.

ORR is defined as the proportion of participants who have a best overall response of CR or PR per RECIST 1.1.

DCR is defined as the proportion of participants who have a best overall response of CR, PR or stable disease (SD) per RECIST 1.1.

PFS is defined as the time from the date of first dosing until the date of radiological or clinical progressive disease per RECIST 1.1 or death from any cause, whichever is earliest.

OS is defined as the time from the date of randomization until the date of death from any cause.

DOR is defined as the time from the date of the first response (CR or PR) per RECIST 1.1 to the date of radiological progression or death, whichever occurs earlier.

AUCinf will be derived from the PK serum samples collected.

AUCinf (%extrap) will be derived from the PK serum samples collected.

AUClast will be derived from the PK serum samples collected.

AUCtau will be derived from the PK serum samples collected.

Cmax will be derived from the PK serum samples collected.

Ctrough will be derived from the PK serum samples collected.

tmax will be derived from the PK serum samples collected.

t1/2 will be derived from the PK serum samples collected.

CL will be derived from the PK serum samples collected.

Vss will be derived from the PK serum samples collected.

Vz will be derived from the PK serum samples collected.

Rac(AUC) will be derived from the PK serum samples collected.

Rac(Cmax) will be derived from the PK serum samples collected.

An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs will be graded using the CTCAE guidelines (Version 4.03).

ECGs will be recorded with the participant in the supine position, after the subject has been lying down for approximately 5 minutes. There should be at least 2 minutes between ECG measurements in case a repeat is needed. Any clinically significant adverse changes on the ECG will be reported as AEs.

Immunogenicity of IMAB362 will be assessed by the frequency of ADA-positive participants.