A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma

Astellas Pharma Inc19 enrolled

Overview

The objective of this study is to assess the safety, tolerability and pharmacokinetics of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma. This study will also assess the immunogenicity as defined by the incidence of anti-drug antibody (ADA) and anti-tumor activity of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma.

All subjects will receive a single 30 minute intravenous (IV) infusion of enfortumab vedotin (ASG-22CE) once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8, and 15). A cycle is 28 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Urothelial Cancer

Interventions

Enfortumab vedotinDRUG

All subjects assigned will receive a single 30 minute intravenous infusion of enfortumab vedotin (ASG-22CE) once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8, and 15). A cycle is 28 days.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject must have histologically confirmed, locally advanced (TNM classification T3b and any N; or T and N2-3) or metastatic Transitional Cell Carcinoma of the Urothelium (TCCU) (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Subjects with Urothelial Carcinoma with squamous differentiation or mixed cell types are eligible. * Subject must be able to submit a tumor tissue samples for Nectin-4 expression analysis at central laboratory. * Subject must have failed at least one prior chemotherapy regimen for advanced disease. Urothelial and bladder cancer subjects are not required to have failed prior chemotherapy regimen if considered unfit for cisplatin-based chemotherapy. * Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumor (RECIST) (version 1.1). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Preexisting sensory neuropathy Grade ≥ 2. * Preexisting motor neuropathy Grade ≥ 2. * Uncontrolled central nervous system metastasis that requires active treatment. * Any anticancer therapy within 14 days prior to the first dose of study drug. * Subjects with pre-existing immunotherapy-related adverse events requiring high doses of systemic steroids are not eligible.

Locations (8)

Site JP00003

Tsukuba, Ibaraki, Japan

Site JP00005

Sendai, Miyagi, Japan

Site JP00008

Suita, Osaka, Japan

Site JP00004

Chuo-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Safety assessed by incidence of adverse events

Adverse events will be coded using MedDRA. Adverse events collection begins after signing informed consent and collected until 28 days after the last dose of study drug.

Time frame: Up to 12 months

Safety assessed by laboratory tests: Hematology

Descriptive statistics will be used to summarize results.

Time frame: Up to 12 months

Safety assessed by laboratory tests: Biochemistry

Descriptive statistics will be used to summarize results.

Time frame: Up to 12 months

Safety assessed by laboratory tests: Urinalysis

Descriptive statistics will be used to summarize results.

Time frame: Up to 12 months

Safety assessed by laboratory tests: Coagulation studies

Descriptive statistics will be used to summarize results.

Time frame: Up to 12 months

Number of participants with vital sign abnormalities and/or adverse events

Number of participants with potentially clinically significant vital sign values.

Time frame: Up to 12 months

Safety assessed by electrocardiogram (ECG)

Before measurement of ECGs, the participant should be resting in a supine position for at least 5 minutes. The investigator will assess the ECG charts as "normal", "abnormal (not clinically significant)" or "abnormal (clinically significant)". "Abnormal (not clinically significant)" and "abnormal (clinically significant)" findings will be recorded.

Time frame: Up to 12 months

Data from ClinicalTrials.gov

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Koto-ku, Tokyo, Japan

Site JP00006

Fukuoka, Japan

Site JP00001

Niigata, Japan

Site JP00002

Okayama, Japan

Pharmacokinetics (PK) parameter for total antibody (TAb): Concentration at the end of infusion (CEOI)

CEOI will be derived from the PK blood samples collected.