Trial · NCT04995419
Outcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| 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 |
| PRIMARY | PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) 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. | days | MEDIAN |
| PRIMARY | PK of ADC, TAb, MMAE in Serum: Area Under Concentration-time Curve From 0 to Day 28 (AUC0-28d) at Cycle 1 Day 1 | Cycle 1 Day 1: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days) | 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. | ||
| PRIMARY | PK of ADC, TAb, MMAE in Serum: Area Under Concentration-time Curve From 0 to Day 28 (AUC0-28d) at Cycle 1 Day 15 | Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days) | 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. | ||
| PRIMARY | PK of ADC, TAb in Serum: Area Under Concentration-time Curve From 0 to Day 7 (AUC0-7d) at Cycle 1 Day 1 | Cycle 1 Day 1 : pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days) | PKAS population with available data were analyzed. | day*ug/mL | MEAN |
| PRIMARY | PK of MMAE in Serum: Area Under Concentration-time Curve From 0 to Day 7 (AUC0-7d) at Cycle 1 Day 1 | Cycle 1 Day 1 : pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days) | PKAS population with available data were analyzed. | day*ng/mL | MEAN |
| PRIMARY | PK of ADC, TAb in Serum: Area Under Concentration-time Curve From 0 to Day 7 (AUC0-7d) 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. | day*ug/mL | MEAN |
| PRIMARY | PK of MMAE in Serum: Area Under Concentration-time Curve From 0 to Day 7 (AUC0-7d) 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. | day*ng/mL | MEAN |
| PRIMARY | PK of ADC, TAb, MMAE in Plasma: Accumulation Ratio of Cmax (RacCmax) | Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days) | PKAS population with available data were analyzed. | ratio | MEAN |
| PRIMARY | PK of ADC, TAb, MMAE in Serum: Accumulation Ratio of AUC0-7d ( RacAUC0-7d) | Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days) | PKAS population with available data were analyzed. | ratio | MEAN |
| PRIMARY | PK of ADC, TAb, MMAE in Serum: Terminal Elimination Half-life (t1/2) | Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days) | PKAS population with available data were analyzed. | days | MEDIAN |
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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