Trial · NCT04995419
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| 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. |
| 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) | Tmax was derived from the PK blood samples collected. |
| 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) | AUC0-28d was derived from the PK blood samples collected. |
| 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) | AUC0-28d was derived from the PK blood samples collected. |
| 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) | AUC0-7d was derived from the PK blood samples collected. |
| 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) | AUC0-7d was derived from the PK blood samples collected. |
| 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) | AUC0-7d was derived from the PK blood samples collected. |
| 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) | AUC0-7d was derived from the PK blood samples collected. |
| 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) | Accumulation ratio is the ratio of Cmax after the dosing interval (Cycle 1 Day 15) divided by Cmax after the first dosing interval (Cycle 1 Day 1). |
| 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) | RacAUC0-7d was calculated using AUC0-7d and derived from the PK blood samples collected. |
| 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) | t1/2 was derived from the PK blood samples collected. |
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/registered