Trial · NCT03833180
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 39
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) of zilovertamab vedotin | Cycle 1 (Up to 21 Days) | Participants will receive zilovertamab vedotin according to Schedule 1, 2, or 3. The MTD will be determined by the number of participants who experience a dose limiting toxicity (DLT). The MTD will be defined as the highest tested dose level at which ≥6 participants have been treated and which is associated with a Cycle 1 DLT in ≤17% of the participants. |
| Primary | Recommended Dosing Regimen (RDR) | Cycle 1 (Up to 21 Days) | Selection of the RDR will be based on consideration of short- and long-term safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data. The RDR may be the MTD or may be a lower dose within the tolerable dose range. |
| Secondary | Average number of zilovertamab vedotin infusions administered | Up to 5 months | Zilovertamab vedotin drug administration will be assessed by prescribing records and the average number of zilovertamab vedotin infusions administered will be determined. |
| Secondary | Number of participants with a treatment-emergent adverse event (TEAE) | Up to approximately 3.5 years | An AE is any untoward medical occurrence in a participant administered a medicinal product; the event does not necessarily have a causal relationship with study drug administration or usage. Laboratory abnormalities, vital sign/oxygen saturation abnormalities, and adverse electrocardiogram (ECG) findings will also be recorded as AEs. A TEAE is defined as an AE that occurs or worsens in the period from the first dose of study drug administration to 30 days after the final dose of study drug administration. The number of participants with a TEAE will be reported for each arm. |
| Secondary | Number of participants with a DLT | Cycle 1 (Up to 21 Days) | A DLT is defined as a protocol pre-specified TEAE that occurs in Cycle 1 of zilovertamab vedotin therapy and is considered drug-related. Failure to recover to baseline by ≥21 days from the last dose of study drug in the current cycle due to a drug-related TEAE is also considered a DLT. The number of participants with a DLT will be reported for each arm. |
| Secondary | Number of participants with a serious adverse event (SAE) | Up to approximately 3.5 years | An SAE is defined as an untoward medical occurrence that results in any of the following outcomes: death, life-threatening situation, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or other medically significant event. |
| Secondary | Number of participants with an adverse event of special interest (AESI) | Up to approximately 3.5 years | Prespecified AESIs for this study will include: Grade ≥3 infusion reactions, tumor lysis syndrome (TLS) of any grade, and Grade ≥3 peripheral neuropathy. The number of participants with an AESI will be reported for each arm. |
| Secondary | Number of participants that discontinue study treatment due to an AE | Up to approximately 3.5 years | An AE is any untoward medical occurrence in a participant administered a medicinal product; the event does not necessarily have a causal relationship with study drug administration or usage. The number of participants that discontinue study treatment due to an AE will be reported for each arm. |
| Secondary | Number of participants that use supportive care or concomitant medications | Up to approximately 3.5 years | The number of participants that use supportive care or concomitant medications will be reported for each arm. |
| Secondary | Plasma concentration of zilovertamab vedotin | Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion | Plasma concentration of zilovertamab vedotin will be reported for each arm. |
| Secondary | Plasma concentration of total UC-961 antibody | Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion | Plasma concentration of total UC-961 antibody will be reported for each arm. |
| Secondary | Plasma concentration of monomethyl auristatin E (MMAE) | Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion | Plasma concentration of MMAE will be reported for each arm. |
| Secondary | Maximum plasma concentration (Cmax) of zilovertamab vedotin | Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion | Blood samples collected predose and at multiple timepoints postdose will be used to determine Cmax of zilovertamab vedotin. |
| Secondary | Time to maximum plasma concentration (Tmax) of zilovertamab vedotin | Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion | Blood samples collected predose and at multiple timepoints postdose will be used to determine Tmax of zilovertamab vedotin. |
| Secondary | Area under the plasma concentration time curve (AUC) of zilovertamab vedotin | Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion | Blood samples collected predose and at multiple timepoints postdose will be used to determine AUC of zilovertamab vedotin. |
| Secondary | Volume of distribution (Vd) of zilovertamab vedotin | Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion | Blood samples collected predose and at multiple timepoints postdose will be used to determine Vd of zilovertamab vedotin. |
| Secondary | Clearance (CL) of zilovertamab vedotin | Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion | Blood samples collected predose and at multiple timepoints postdose will be used to determine CL of zilovertamab vedotin. |
| Secondary | Apparent terminal half-life (t½) of plasma concentration of zilovertamab vedotin | Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion | Blood samples collected predose and at multiple timepoints postdose will be used to determine t1/2 of plasma concentration of zilovertamab vedotin. |
| Secondary | Cmax of total UC-961 antibody | Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion | Blood samples collected predose and at multiple timepoints postdose will be used to determine Cmax of total UC-961 antibody. |
| Secondary | Tmax of total UC-961 antibody | Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion | Blood samples collected predose and at multiple timepoints postdose will be used to determine Tmax of total UC-961 antibody. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03833180/registered