Trial · NCT06941272
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs) | Cycle 1 (up to approximately 21 days); each cycle is 21 days | A DLT is any of a prespecified list of adverse events (AEs) that occur during Cycle 1 (up to 21 days) if attributed to the study treatment and not attributed to any other clearly identifiable cause. The percentage of participants who experience DLTs will be reported. Each cycle is 21 days. |
| Primary | Part 1: Percentage of Participants Who Experience an Adverse Event (AE) | Up to approximately 5 years | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience AEs will be reported. |
| Primary | Part 1: Percentage of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 5 years | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported. |
| Primary | Part 1: Area Under the Curve (AUC) of total anti-HER3 antibody liquid chromatography-mass spectrometry (LC-MS) in plasma | At designated timepoints (up to approximately 5 years) | Blood samples will be collected at specified intervals for the determination of AUC. |
| Primary | Part 1: AUC of anti-HER3 antibody-conjugated DXd (anti-HER3-ac-DXd) in plasma | At designated timepoints (up to approximately 5 years) | Blood samples will be collected at specified intervals for the determination of AUC. |
| Primary | Part 1: AUC of DXd in plasma | At designated timepoints (up to approximately 5 years) | Blood samples will be collected at specified intervals for the determination of AUC. |
| Primary | Part 1: Maximum Concentration (Cmax) of anti-HER3 antibody LC-MS in plasma | At designated timepoints (up to approximately 5 years) | Blood samples will be collected at specified intervals for the determination of Cmax. |
| Primary | Part 1: Cmax of anti-HER3-ac-DXd in plasma | At designated timepoints (up to approximately 5 years) | Blood samples will be collected at specified intervals for the determination of Cmax. |
| Primary | Part 1: Cmax of DXd in plasma | At designated timepoints (up to approximately 5 years) | Blood samples will be collected at specified intervals for the determination of Cmax. |
| Primary | Part 1: Concentration Immediately Before the Next Dose is Administered (Ctrough) of anti-HER3 antibody LC-MS in plasma | At designated timepoints (up to approximately 5 years) | Blood samples will be collected at specified intervals for the determination of Ctrough. |
| Primary | Part 1: Ctrough of anti-HER3-ac-DXd | At designated timepoints (up to approximately 5 years) | Blood samples will be collected at specified intervals for the determination of Ctrough. |
| Primary | Part 1: Ctrough of DXd in plasma | At designated timepoints (up to approximately 5 years) | Blood samples will be collected at specified intervals for the determination of Ctrough. |
| Primary | Part 1 and Part 2: Objective Response Rate (ORR) | Up to approximately 5 years | ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by the investigator will be presented. |
| Secondary | Part 2: Percentage of Participants Who Experience an AE | Up to approximately 5 years | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience AEs will be reported. |
| Secondary | Part 2: Percentage of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 5 years | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported. |
| Secondary | Part 1 and Part 2: Disease Control Rate (DCR) | Up to approximately 5 years | DCR is defined, per RECIST 1.1, as the percentage of participants who have a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD). SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm). Note: The appearance of one or more new lesions is also considered PD. The time from the first dose until the date of SD must be greater than or equal to 6 weeks. The DCR as assessed by the investigator will be presented. |
| Secondary | Part 1 and Part 2: Time to Response (TTR) | Up to approximately 5 years | For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, TTR is defined as the time from the first dose to the first documented evidence of a CR or PR. The TTR as assessed by the investigator will be presented. |
| Secondary | Part 1 and Part 2: Duration of Response (DOR) | Up to approximately 5 years | For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. PD is defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator will be presented. |
| Secondary | Part 1 and Part 2: Progression-free Survival (PFS) | Up to approximately 5 years | PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions is also considered PD. PFS as assessed by the investigator will be presented. |
| Secondary | Part 1 and Part 2: Overall Survival (OS) | Up to approximately 5 years | OS is defined as time from first dose of study treatment to death due to any cause. |
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.
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GET https://conductscience.org/api/trials/v1/NCT06941272/registered