TriangleNCT03070990 · CITED IN SOURCE DOCUMENTS
A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE1
- Status at capture
- COMPLETED
- Registry last update
- 2024-10-18
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.
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What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- 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.
- healthy Volunteers
- false
- minimum Age
- 20 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- 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.
- intervention Names
- Drug: Enfortumab vedotin
- label
- Arm A: Enfortumab vedotin 1.0 mg/kg
- type
- EXPERIMENTAL
- description
- 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.
- intervention Names
- Drug: Enfortumab vedotin
- label
- Arm B: Enfortumab vedotin 1.25 mg/kg
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Arm A: Enfortumab vedotin 1.0 mg/kg
- Arm B: Enfortumab vedotin 1.25 mg/kg
- description
- 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.
- name
- Enfortumab vedotin
- other Names
- ASG-22CE
- Padcev
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 19
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Safety assessed by incidence of adverse events
- time Frame
- Up to 12 months
- description
- Descriptive statistics will be used to summarize results.
- measure
- Safety assessed by laboratory tests: Hematology
- time Frame
- Up to 12 months
- description
- Descriptive statistics will be used to summarize results.
- measure
- Safety assessed by laboratory tests: Biochemistry
- time Frame
- Up to 12 months
- description
- Descriptive statistics will be used to summarize results.
- measure
- Safety assessed by laboratory tests: Urinalysis
- time Frame
- Up to 12 months
- description
- Descriptive statistics will be used to summarize results.
- measure
- Safety assessed by laboratory tests: Coagulation studies
- time Frame
- Up to 12 months
- description
- Number of participants with potentially clinically significant vital sign values.
- measure
- Number of participants with vital sign abnormalities and/or adverse events
- time Frame
- Up to 12 months
- description
- 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.
- measure
- Safety assessed by electrocardiogram (ECG)
- time Frame
- Up to 12 months
- description
- CEOI will be derived from the PK blood samples collected.
- measure
- Pharmacokinetics (PK) parameter for total antibody (TAb): Concentration at the end of infusion (CEOI)
- time Frame
- Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
- description
- CEOI will be derived from the PK blood samples collected.
- measure
- Pharmacokinetics (PK) parameter for antibody drug conjugate (ADC): CEOI
- time Frame
- Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
- description
- CEOI will be derived from the PK blood samples collected.
- measure
- Pharmacokinetics (PK) parameter for Monomethyl Auristatin E (MMAE): CEOI
- time Frame
- Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
- description
- Cmax will be derived from the PK blood samples collected.
- measure
- PK parameter for TAb: Maximum observed concentration (Cmax)
- time Frame
- Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
- description
- Cmax will be derived from the PK blood samples collected.
- measure
- PK parameter for ADC: Cmax
- time Frame
- Days 1-4, 8, 15-18, 22 of Cycle 1, Day 1 of Cycle 2 and 3, and subsequent cycles up to an average of 12 months
- secondary Outcomes
- description
- Blood samples for anti-drug antibody (ADA) analysis will be collected.
- measure
- Incidence of Anti-Drug Antibody (ADA)
- time Frame
- Up to 12 months
- description
- Defined as the proportion of subjects whose best overall response is rated as complete response (CR) or partial response (PR)
- measure
- Overall Response Rate
- time Frame
- Up to 12 months
- description
- Defined as the proportion of subjects whose best overall response is rated as CR, PR, or stable disease (SD)
- measure
- Disease Control Rate
- time Frame
- Up to 12 months
Full study description
- brief Summary
- 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.
- detailed Description
- 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.
Source references
- references
- citation
- Takahashi S, Uemura M, Kimura T, Kawasaki Y, Takamoto A, Yamaguchi A, Melhem-Bertrandt A, Gartner EM, Inoue T, Akazawa R, Kadokura T, Tanikawa T. A phase I study of enfortumab vedotin in Japanese patients with locally advanced or metastatic urothelial carcinoma. Invest New Drugs. 2020 Aug;38(4):1056-1066. doi: 10.1007/s10637-019-00844-x. Epub 2019 Aug 14.
- pmid
- 31444589
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- occurrences
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- ; PADCEV as a single agent at 1.25 mg/kg in 720 patients in EV-301 (NCT03474107), EV‑201 (NCT03219333), EV-203 (NCT04995419), EV-101 (NCT02091999), and EV-102 (NCT03070990). Ocular disorders reflect 384 patients in EV‑201, EV-101, and EV-102. Among 570 patients receiving PADCEV in combination with intravenous pembrolizumab for th
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Preserved source evidence · Not medical advice