Trial · NCT06172478
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Objective Response Rate Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) | Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months | Confirmed objective response rate (ORR) is defined as the sum of the complete response (CR) rate and partial response (PR) rate based on investigator by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. |
| Primary | Proportion of Participants Achieving a ≥50% Decrease in PSA (Prostate Cancer Cohort Only) | Baseline, each cycle before infusion (each cycle is 21 days), and end of treatment, up to approximately 27 months | |
| Secondary | Overall Number of Participants With Treatment-emergent Adverse Events Following HER3-DXd Monotherapy (All Cohorts) | Baseline up to 27 months | Adverse events (AEs) will be coded using MedDRA and AEs and will be graded by using NCI-CTCAE v5.0. |
| Secondary | Duration of Response As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) | From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first, up to approximately 27 months | Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first documentation of progressive disease (PD) or death. The DoR will be calculated for responding participants (PR or CR) only. |
| Secondary | Clinical Benefit Rate As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) | Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months | Clinical benefit rate (CBR) is the proportion of participants with a best overall response of confirmed CR, confirmed PR, or SD lasting ≥183 days. |
| Secondary | Disease Control Rate As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) | Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months | Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) by investigator assessment per RECIST v1.1. |
| Secondary | Time to Response As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) | From the start date of study drug to the date of the first documentation of response (CR or PR) that is subsequently confirmed, up to approximately 27 months | Time to response (TTR) will be calculated for confirmed responders only. |
| Secondary | Progression-free Survival As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) | From the start date of study drug to the earlier date of the first objective documentation of radiographic disease progression as assessed by investigator per RECIST v1.1 or death due to any cause, whichever occurs first, up to approximately 27 months | |
| Secondary | Overall Survival Following HER3-DXd Monotherapy (All Cohorts) | From the start date of study drug to the date of death due to any cause, whichever occurs first, up to approximately 27 months | |
| Secondary | Pharmacokinetic Parameter Maximum Serum Concentration for HER3-DXd (All Cohorts) | Cycles 1-4, 6, 8: Day 1, predose and postdose; Cycles 1 and 3: Day 1, 2 hours and 4 hours postdose; Cycles 1 and 3: Day 8, Day 15 (each cycle is 21 days) | Maximum serum concentration (Cmax) will be assessed using non-compartmental methods. |
| Secondary | Pharmacokinetic Parameter Time to Maximum Serum Concentration for HER3-DXd (All Cohorts) | Cycles 1-4, 6, 8: Day 1, predose and postdose; Cycles 1 and 3: Day 1, 2 hours and 4 hours postdose; Cycles 1 and 3: Day 8, Day 15 (each cycle is 21 days) | Time to maximum serum concentration (Tmax) will be assessed using non-compartmental methods. |
| Secondary | Pharmacokinetic Parameter Trough Serum Concentration (Ctrough) for HER3-DXd (All Cohorts) | Cycles 1-4, 6, 8: Day 1, predose and postdose; Cycles 1 and 3: Day 1, 2 hours and 4 hours postdose; Cycles 1 and 3: Day 8, Day 15 (each cycle is 21 days) | Trough serum concentration (Ctrough) will be assessed using non-compartmental methods. |
| Secondary | Pharmacokinetic Parameter Area Under the Concentration Curve for HER3-DXd (All Cohorts) | Cycles 1-4, 6, 8: Day 1, predose and postdose; Cycles 1 and 3: Day 1, 2 hours and 4 hours postdose; Cycles 1 and 3: Day 8, Day 15 (each cycle is 21 days) | Area under the concentration-time curve up to the last quantifiable time (AUClast) and Area under the concentration-time curve during dosing interval (AUCtau) will be assessed using non-compartmental methods. |
| Secondary | Radiographic Progression-free Survival (rPFS) As Assessed by Prostate Cancer Working Group 3 (PCWG3) Criteria by the Investigator or Death Due to Any Cause Following HER3-DXd Monotherapy (Prostate Cancer Cohort Only) | From the start date of study drug to the earlier date of the first objective documentation of radiographic disease progression as assessed per PCWG3 criteria by investigator or death due to any cause, whichever occurs first, up to approximately 27 months | |
| Secondary | Proportion of Participants Achieving a ≥30% Decrease in PSA (Prostate Cancer Cohort Only) | Baseline, each cycle before infusion (each cycle is 21 days), and end of treatment, up to approximately 27 months | |
| Secondary | Time to First Subsequent Anticancer Therapy (TFST) (Prostate Cancer Cohort Only) | From the start date of study drug to initiation of the first subsequent anticancer therapy or death, whichever occurs first, up to approximately 27 months | |
| Secondary | Time to First Symptomatic Skeletal-Related Event (SSRE) (Prostate Cancer Cohort Only) | From start date of study drug to the first occurrence of any of the following: Use of EBRT, New symptomatic pathologic bone fracture, Spinal cord compression, A tumor-related orthopedic surgical intervention, up to approximately 27 months | |
| Secondary | Correlation Between HER3 Protein Expression and Efficacy | From the start date of study drug up to approximately 27 months | HER3 protein expression in tumor tissue as determined by IHC and correlation with ORR, DoR, and PFS. |
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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