Trial · NCT04995419
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
NCT04995419, Phase 2, Completed, Astellas Pharma China, Inc.; results first posted 2023-09-13
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. 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. Trials, record NCT04995419. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04995419
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT04995419
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Astellas Pharma China, Inc.
- Conditions
- Metastatic Urothelial Cancer
- Interventions
- Enfortumab vedotin
- First posted
- 2021-08-09
- Last updated
- 2026-10-02
- Results first posted
- 2023-09-13
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors V1.1 (RECIST V1.1) | From first dose up to progressive disease or death (maximum duration: 9.33 months) | 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. |
| Primary | Pharmacokinetics (PK) of Antibody-Drug Conjugate (ADC), Total Antibody (TAb), in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 1 | Cycle 1 Day 1: pre-dose, end of infusion (EOI), 2 hour, 4 hour post-dose (each cycle = 28 days) | Cmax was derived from the PK blood samples collected. |
| Primary | PK of Monomethyl Auristatin E (MMAE) in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 1 | Cycle 1 Day 1: pre-dose, end of infusion (EOI), 2 hour, 4 hour post-dose (each cycle = 28 days) | Cmax was derived from the PK blood samples collected. |
| Primary | PK of ADC, TAb in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 15 | Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days) | Cmax was derived from the PK blood samples collected. |
| Primary | PK of MMAE in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 15 | Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days) | Cmax was derived from the PK blood samples collected. |
| Primary | PK of ADC , TAb in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 1 | Cycle 1 Day 1: pre-dose | 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. |
| Primary | PK of MMAE in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 1 | Cycle 1 Day 1: pre-dose | 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. |
| Primary | PK of ADC, TAb in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 15 | Cycle 1 Day 15: pre-dose | Ctrough was derived from the PK blood samples collected. |
| Primary | PK of MMAE in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 15 | Cycle 1 Day 15: pre-dose | Ctrough was derived from the PK blood samples collected. |
| Primary | PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 1 | Cycle 1 Day 1: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days) | Tmax was derived from the PK blood samples collected. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors V1.1 (RECIST V1.1) | From first dose up to progressive disease or death (maximum duration: 9.33 months) | FAS population | percentage of participants | NUMBER |
| PRIMARY | Pharmacokinetics (PK) of Antibody-Drug Conjugate (ADC), Total Antibody (TAb), in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 1 | Cycle 1 Day 1: pre-dose, end of infusion (EOI), 2 hour, 4 hour post-dose (each cycle = 28 days) | 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. | micrograms per milliliter (ug/mL) | MEAN |
| PRIMARY | PK of Monomethyl Auristatin E (MMAE) in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 1 | Cycle 1 Day 1: pre-dose, end of infusion (EOI), 2 hour, 4 hour post-dose (each cycle = 28 days) | PKAS population. | nanograms per milliliter (ng/mL) | MEAN |
| PRIMARY | PK of ADC, TAb in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 15 | Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days) | PKAS population with available data were analyzed. | ug/mL | MEAN |
| PRIMARY | PK of MMAE in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 15 | Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days) | PKAS population with available data were analyzed. | ng/mL | MEAN |
| PRIMARY | PK of ADC , TAb in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 1 | Cycle 1 Day 1: pre-dose | PKAS population. | ug/mL | MEAN |
| PRIMARY | PK of MMAE in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 1 | Cycle 1 Day 1: pre-dose | PKAS population. | ng/mL | MEAN |
| PRIMARY | PK of ADC, TAb in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 15 | Cycle 1 Day 15: pre-dose | PKAS population with available data were analyzed. | ug/mL | MEAN |
| PRIMARY | PK of MMAE in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 15 | Cycle 1 Day 15: pre-dose | PKAS population with available data were analyzed. | picograms per milliliter (pg/mL) | MEAN |
| PRIMARY | PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 1 | Cycle 1 Day 1: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days) | PKAS population. | days | MEDIAN |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group59
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors V1.1 (RECIST V1.1) | Enfortumab Vedotin 1.25 mg/kg | 37.5 | 95% Confidence Interval 22.7 to 54.2 | percentage of participants | |
| Pharmacokinetics (PK) of Antibody-Drug Conjugate (ADC), Total Antibody (TAb), in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 1 | Enfortumab Vedotin 1.25 mg/kg | ADC | 28.1 | Standard Deviation 4.52 | micrograms per milliliter (ug/mL) |
| Pharmacokinetics (PK) of Antibody-Drug Conjugate (ADC), Total Antibody (TAb), in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 1 | Enfortumab Vedotin 1.25 mg/kg | TAb | 31.7 | Standard Deviation 5.73 | micrograms per milliliter (ug/mL) |
| PK of Monomethyl Auristatin E (MMAE) in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 1 | Enfortumab Vedotin 1.25 mg/kg | 3.33 | Standard Deviation 1.74 | nanograms per milliliter (ng/mL) | |
| PK of ADC, TAb in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 15 | Enfortumab Vedotin 1.25 mg/kg | ADC | 27.6 | Standard Deviation 4.01 | ug/mL |
| PK of ADC, TAb in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 15 | Enfortumab Vedotin 1.25 mg/kg | TAb | 34.4 | Standard Deviation 4.64 | ug/mL |
| PK of MMAE in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 15 | Enfortumab Vedotin 1.25 mg/kg | 4.49 | Standard Deviation 3.58 | ng/mL | |
| PK of ADC , TAb in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 1 | Enfortumab Vedotin 1.25 mg/kg | ADC | 0 | Standard Deviation NA | ug/mL |
| PK of ADC , TAb in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 1 | Enfortumab Vedotin 1.25 mg/kg | TAb | 0 | Standard Deviation NA | ug/mL |
| PK of MMAE in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 1 | Enfortumab Vedotin 1.25 mg/kg | 0 | Standard Deviation NA | ng/mL |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Enfortumab Vedotin 1.25 mg/kg | 40 | |
| Overall Study | COMPLETED | Enfortumab Vedotin 1.25 mg/kg | 0 | |
| Overall Study | NOT COMPLETED | Enfortumab Vedotin 1.25 mg/kg | 40 |
Source ClinicalTrials.gov
Adverse events122
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Enfortumab Vedotin 1.25 mg/kg | 28 | 40 | 81 |
| other | Leukopenia | Blood and lymphatic system disorders | Enfortumab Vedotin 1.25 mg/kg | 2 | 40 | 2 |
| other | Sinus tachycardia | Cardiac disorders | Enfortumab Vedotin 1.25 mg/kg | 4 | 40 | 6 |
| other | Dry eye | Eye disorders | Enfortumab Vedotin 1.25 mg/kg | 3 | 40 | 3 |
| other | Eye discharge | Eye disorders | Enfortumab Vedotin 1.25 mg/kg | 5 | 40 | 5 |
| other | Vision blurred | Eye disorders | Enfortumab Vedotin 1.25 mg/kg | 2 | 40 | 2 |
| other | Abdominal discomfort | Gastrointestinal disorders | Enfortumab Vedotin 1.25 mg/kg | 4 | 40 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Enfortumab Vedotin 1.25 mg/kg | 4 | 40 | 5 |
| other | Abdominal pain upper | Gastrointestinal disorders | Enfortumab Vedotin 1.25 mg/kg | 5 | 40 | 5 |
| other | Constipation | Gastrointestinal disorders | Enfortumab Vedotin 1.25 mg/kg | 19 | 40 | 25 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enfortumab Vedotin 1.25 mg/kg | 10 | 40 |
| Total, other adverse events | Enfortumab Vedotin 1.25 mg/kg | 40 | 40 |
| Total, serious adverse events | Enfortumab Vedotin 1.25 mg/kg | 18 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39530574 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04995419
GET https://conductscience.org/api/trials/v1/NCT04995419/registered?page=2