Trial · NCT04995419
Results by group59
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 59
Download this page as JSON| 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 | |
| PK of ADC, TAb in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 15 | Enfortumab Vedotin 1.25 mg/kg | ADC | 1020 | Standard Deviation 410 | ug/mL |
| PK of ADC, TAb in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 15 | Enfortumab Vedotin 1.25 mg/kg | TAb | 4620 | Standard Deviation 1590 | ug/mL |
| PK of MMAE in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 15 | Enfortumab Vedotin 1.25 mg/kg | 1880 | Standard Deviation 1680 | picograms per milliliter (pg/mL) | |
| PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 1 | Enfortumab Vedotin 1.25 mg/kg | ADC | 0.0340 | Full Range 0.0278 to 0.0917 | days |
| PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 1 | Enfortumab Vedotin 1.25 mg/kg | TAb | 0.0340 | Full Range 0.0243 to 1.89 | days |
| PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 1 | Enfortumab Vedotin 1.25 mg/kg | MMAE | 2.00 | Full Range 1.87 to 2.93 | days |
| PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 15 | Enfortumab Vedotin 1.25 mg/kg | ADC | 0.0337 | Full Range 0.0257 to 0.0805 | days |
| PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 15 | Enfortumab Vedotin 1.25 mg/kg | TAb | 0.0337 | Full Range 0.0278 to 0.0854 | days |
| PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 15 | Enfortumab Vedotin 1.25 mg/kg | MMAE | 1.93 | Full Range 0.858 to 2.92 | days |
| PK of ADC, TAb in Serum: Area Under Concentration-time Curve From 0 to Day 7 (AUC0-7d) at Cycle 1 Day 1 | Enfortumab Vedotin 1.25 mg/kg | ADC | 32.4 | Standard Deviation 6.24 | day*ug/mL |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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GET https://conductscience.org/api/trials/v1/NCT04995419/results