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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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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas’ data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Participants received 1.25 milligrams per kilogram (mg/kg) of body weight enfortumab vedotin by intravenous (IV) infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first. Participants who had intense PK Sampling were enrolled in PK Cohort.

The purpose of this study was to determine the antitumor activity of enfortumab vedotin (EV) confirmed by the objective response rate (ORR). 

This study also evaluated the effect of  antibody-drug conjugate (ADC), total antibody (TAb) and monomethyl auristatin E (MMAE) in Chinese participants with locally advanced or metastatic urothelial cancer.

In addition, the study also evaluated the duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and immunogenicity determined by the incidence of antitherapeutic antibodies (ATA).

Safety and tolerability of EV in participants with locally advanced or metastatic urothelial cancer was also evaluated.

A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants with Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and programmed cell death protein-1 ( PD 1) / (programmed death ligand-1 (PD-L1) Inhibitor Therapy

This study comprised of a single group of participants who received one dose of enfortumab vedotin (EV) on Days 1, 8 and 15 of every 4-week (28 days) cycle. Participants continued on study treatment until discontinuation. 

After treatment discontinuation, participant had an end of treatment (EOT) visit for a 30-day Safety Follow-up. 

Participants to discontinue to treatment for reasons other than disease progression were followed for response assessments.

A Pharmacokinetic (PK) cohort was available at some study centers. Participants enrolled at the PK cohort site(s) had intense PK samples collected after single and repeated doses.

AST Biomarker Conditions ST

CN CDE Number

CTIS Number

EudraCT Number

jRCT Number

NCT ID

Patient Level Data

Product ST Name

Therapeutic Area

Site CN86001

Site CN86006

Site CN86003

Site CN86007

Site CN86002

Site CN86009

Site CN86011

Site CN86004

A Single-arm, Open-label, Multi-center Phase 2 Study of Enfortumab Vedotin (ASG-22CE) in Chinese Subjects with Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and PD 1/PD-L1 Inhibitor Therapy (EV-203)

The ORR is defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST V 1.1.

Cmax will be recorded from PK blood samples collected.

Ctrough will be recorded from PK blood samples collected

Tmax will be recorded from PK blood samples collected.

AUC0-7d will be recorded from PK blood samples collected.

AUC0-28d will be recorded from PK blood samples collected.

Rac[Cmax] will be recorded from PK blood samples collected.

Rac[AUC0-7d] will be recorded from PK blood samples collected.

t1/2 will be recorded from PK blood samples collected.

Vss will be recorded from PK blood samples collected.

CL will be recorded from PK blood samples collected.

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

Full analysis set (FAS) included all participants who were enrolled and received any amount of study drug in the study.

ORR was defined as the percentage of participants with best overall response (BOR) as complete response (CR) or partial response (PR) based on the RECIST v1.1. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters.

Objective Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors V1.1 (RECIST V1.1)

Cmax was derived from the PK blood samples collected.

Pharmacokinetic Analysis Set (PKAS) included all participants in the PK cohort who had received at least 3 of 4 doses up through Cycle 2 Day 1, and had at least 5 blood samples collected and assayed for measurement of ADC, TAb or unconjugated MMAE serum/plasma concentrations to determine at least 1 PK parameter.

Pharmacokinetics (PK) of Antibody-Drug Conjugate (ADC), Total Antibody (TAb), in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 1

PK of Monomethyl Auristatin E (MMAE) in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 1

PKAS population with available data were analyzed.

PK of ADC, TAb in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 15

PK of MMAE in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 15

As per planned analysis, if more than 50% of PK concentrations were below the limit of quantification (i.e 0) at a given time point, standard deviation was not reported.

PK of ADC , TAb in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 1

PK of MMAE in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 1

Ctrough was derived from the PK blood samples collected.

PK of ADC, TAb in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 15

PK of MMAE in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 15

MMAE

Tmax was derived from the PK blood samples collected.

PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 1

PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 15

AUC0-28d was derived from the PK blood samples collected.

Per protocol, data for AUC0-28d was planned to be calculated using non-compartment analysis (NCA) only if data permits, therefore AUC 0-28d was removed from the planned analysis in SAP.

PK of ADC, TAb, MMAE in Serum: Area Under Concentration-time Curve From 0 to day 28 (AUC0-28d) at Cycle 1 Day 1

AUC0-28d was derived from the PK blood samples collected.

PK of ADC, TAb, MMAE in Serum: Area Under Concentration-time Curve From 0 to day 28 (AUC0-28d) at Cycle 1 Day 15

AUC0-7d was derived from the PK blood samples collected.

PK of ADC, TAb in Serum: Area Under Concentration-time Curve From 0 to day 7 (AUC0-7d) at Cycle 1 Day 1

PK of MMAE in Serum: Area Under Concentration-time Curve From 0 to day 7 (AUC0-7d) at Cycle 1 Day 1

PK of ADC, TAb in Serum: Area Under Concentration-time Curve From 0 to day 7 (AUC0-7d) at Cycle 1 Day 15

PK of MMAE in Serum: Area Under Concentration-time Curve From 0 to day 7 (AUC0-7d) at Cycle 1 Day 15

Accumulation ratio is the ratio of Cmax after the dosing interval (Cycle 1 Day 15) divided by Cmax after the first dosing interval (Cycle 1 Day 1).

PK of ADC, TAb, MMAE in Plasma: Accumulation ratio of Cmax (RacCmax)

RacAUC0-7d was calculated using AUC0-7d and derived from the PK blood samples collected.

PK of ADC, TAb, MMAE in Serum: Accumulation ratio of AUC0-7d ( RacAUC0-7d)

t1/2 was derived from the PK blood samples collected.

PK of ADC, TAb, MMAE in Serum: Terminal Elimination Half-life (t1/2)

CL was derived from the PK blood samples collected.

PK of ADC, TAb, MMAE in Serum: Systemic Clearance (CL)

Vss was derived from the PK blood samples collected.

PK of ADC, TAb, MMAE in Serum: Volume of Distribution at Steady State (Vss)

DOR: time from the date of the first CR/PR (whichever is first recorded) that was subsequently confirmed as assessed by IRC to the date of documented progressive disease. or death due to any cause whichever occurred first. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. Progressive Disease:>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of >= 5 mm. Appearance of 1 or more new lesions is also considered progression.

FAS population with available data were analyzed.

Duration of Response (DOR) as Per RECIST V1.1 per IRC

DOR: time from the date of the first CR/PR (whichever is first recorded) that was subsequently confirmed as assessed by Investigator's Assesment to the date of documented progressive disease or death due to any cause whichever occurred first. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. Progressive disease:>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of >= 5 mm. Appearance of 1 or more new lesions is also considered progression.

Duration of Response (DOR) as Per RECIST V1.1 per Investigator's Assessment

ORR was defined as the percentage of participants with BOR as CR or PR based on the RECIST v1.1 as per investigator's assesment. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters.

Objective Response Rate (ORR) as Per Investigator Assessment

DCR: percentage of participants with a CR, PR or SD based on RECIST v1.1 as assessed by IRC. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. SD was defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum of diameters while on study drug. Progressive disease:>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of >= 5 mm. Appearance of 1 or more new lesions is also considered progression.

Disease Control Rate (DCR) as Per RECIST V1.1 per IRC

DCR: percentage of participants with a CR, PR or SD based on RECIST v1.1 as assessed by investigator's assessment. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. SD was defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum of diameters while on study drug. Progressive disease:>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of >= 5 mm. Appearance of 1 or more new lesions is also considered progression.

Disease Control Rate (DCR) as Per RECIST V1.1 Per  Investigator's Assesment

PFS: time from first dose of the study drug until date of documented radiological disease progression per IRC based on RECIST V1.1, or until death due to any cause, whichever occurred first. Progressive disease: >= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of >= 5 mm. Appearance of 1 or more new lesions is also considered progression. A participant who neither progressed nor died was censored at date of last radiological assessment (RA)/ date of randomization if no post-baseline RA was available. Participants who received any further anticancer therapy (ACT) for disease before radiological progression was censored at date of last RA before ACT started and participants who had PD/death after >=2 missed RAs were censored at last RA prior to 2 or more missed RAs. Kaplan-Meier estimates was used.

Progression Free-Survival per RECIST V1.1 per IRC

PFS: time from first dose of the study drug until date of documented radiological disease progression per investigator based on RECIST V1.1, or until death due to any cause, whichever occurred first. Progressive disease: >= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of >= 5 mm. Appearance of 1 or more new lesions is also considered progression. A participant who neither progressed nor died was censored at date of last RA/ date of randomization if no post-baseline RA was available. Participants who received any further ACT for disease before radiological progression was censored at date of last RA before ACT started and participants who had progressive disease/death after >=2 missed RAs were censored at last RA prior to 2 or more missed RAs. Kaplan-Meier estimates was used.

Progression Free-Survival per RECIST V1.1 per Investigator's Assessment

OS was defined as the time from first dose of the study drug until the documented date of death from any cause. OS was analyzed using Kaplan-Meier estimates. Participants who were still alive at the time of data cutoff date were to be censored at the last known alive date or at the data cutoff date, whichever was earlier.

Overall Survival (OS)

Number of participants with ATA were reported.

Number of Participants With Antitherapeutic Antibodies (ATA)

An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE is defined as an adverse event observed after starting administration of the study drug and within 30 days after taking the last dose of study drug.

Safety analysis set (SAF) included all participants who were enrolled and received any amount of study drug in the study.

Number of Participants With Treatment Emergent Adverse Events

ECOG PS= 0

ECOG PS= 1

ECOG PS= 2

ECOG PS= 3

ECOG PS= 4

ECOG PS= 5

ECOG performance status was measured on an 6 point scale. 
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.
5-Dead.
Number of participants with ECOG PS was reported."

Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

Overall Study

Participants who met inclusion criteria and none of the exclusion criteria were enrolled.

Clinical Transparency

ORR is defined as the proportion of participants with a complete or partial objective response confirmed per RECIST V1.1

Duration of response per independent review committee (IRC) is defined as the time from first documentation of objective response (complete response [CR] or partial response [PR] that is subsequently confirmed) to the first documentation of progressive disease (PD) based on IRC assessment or to death due to any cause, whichever comes first. DOR will only be calculated for the participants achieving a confirmed CR or PR.

Duration of response per investigator is defined as the time from first documentation of objective response (complete response [CR] or partial response [PR] that is subsequently confirmed) to the first documentation of progressive disease (PD) based on Investigator assessment or to death due to any cause, whichever comes first. DOR will only be calculated for the participants achieving a confirmed CR or PR.

DCR per IRC is defined as the proportion of participants whose best overall response is a CR, PR or stable disease (SD) according to RECIST V 1.1 based on IRC assessment. Responses do not need to be confirmed to be scored as responders for the purpose of determining DCR.

DCR per Investigator is defined as the proportion of participants whose best overall response is a CR, PR or stable disease (SD) according to RECIST V 1.1 based on Investigator assessment. Responses do not need to be confirmed to be scored as responders for the purpose of determining DCR.

PFS per IRC is defined as the time from start of study treatment to first documentation of objective tumor progression (PD per RECIST V 1.1) based on IRC assessment, or to death due to any cause, whichever comes first.

PFS per Investigator is defined as the time from start of study treatment to first documentation of objective tumor progression (PD per RECIST V 1.1) based on Investigator assessment, or to death due to any cause, whichever comes first.

OS is defined as the time from start of study treatment to the date of death due to any cause.

To be summarized using descriptive statistics.

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study IP. “Adverse event” means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study IP. This includes events related to the comparator and events related to the (study) procedures.

Number of participants with potentially clinically significant laboratory values.

Number of participants with potentially clinically significant vital signs values.

Number of participants with potentially clinically significant 12-lead ECG values.

ECOG performance status will be summarized using descriptive statistics.