Hepatoblastoma, Rhabdomyosarcoma
Conditions
Brief summary
Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs), Part 1: Percentage of Participants Who Experience an Adverse Event (AE), Part 1: Percentage of Participants Who Discontinue Study Treatment Due to an AE, Part 1: Area Under the Curve (AUC) of total anti-HER3 antibody liquid chromatography-mass spectrometry (LC-MS) in plasma, Part 1: AUC of anti-HER3 antibody-conjugated DXd (anti-HER3-ac-DXd) in plasma, Part 1: AUC of DXd in plasma, Part 1: Maximum Concentration (Cmax) of anti-HER3 antibody LC-MS in plasma, Part 1: Cmax of anti-HER3-ac-DXd in plasma, Part 1: Cmax of DXd in plasma, Part 1: Concentration Immediately Before the Next Dose is Administered (Ctrough) of anti-HER3 antibody LC-MS in plasma, Part 1: Ctrough of anti-HER3-ac-DXd, Part 1: Ctrough of DXd in plasma, Part 1 and Part 2: Objective Response Rate (ORR)
Detailed description
Part 2: Percentage of Participants Who Experience an AE, Part 2: Percentage of Participants Who Discontinue Study Treatment Due to an AE, Part 1 and Part 2: Disease Control Rate (DCR), Part 1 and Part 2: Time to Response (TTR), Part 1 and Part 2: Duration of Response (DOR), Part 1 and Part 2: Progressive-free Survival (PFS), Part 1 and Part 2: Overall Survival (OS), Part 2: AUC of total anti-HER3 antibody LC-MS in plasma, Part 2: AUC of anti-HER3-ac-DXd in plasma, Part 2: AUC of DXd in plasma, Part 2: Cmax of anti-HER3 antibody LC-MS in plasma, Part 2: Cmax of anti-HER3-ac-DXd in plasma, Part 2: Cmax of DXd in plasma, Part 2: Ctrough of anti-HER3 antibody LC-MS in plasma, Part 2: Ctrough of anti-HER3-ac-DXd in plasma, Part 2: Ctrough of DXd in plasma
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs), Part 1: Percentage of Participants Who Experience an Adverse Event (AE), Part 1: Percentage of Participants Who Discontinue Study Treatment Due to an AE, Part 1: Area Under the Curve (AUC) of total anti-HER3 antibody liquid chromatography-mass spectrometry (LC-MS) in plasma, Part 1: AUC of anti-HER3 antibody-conjugated DXd (anti-HER3-ac-DXd) in plasma, Part 1: AUC of DXd in plasma, Part 1: Maximum Concentration (Cmax) of anti-HER3 antibody LC-MS in plasma, Part 1: Cmax of anti-HER3-ac-DXd in plasma, Part 1: Cmax of DXd in plasma, Part 1: Concentration Immediately Before the Next Dose is Administered (Ctrough) of anti-HER3 antibody LC-MS in plasma, Part 1: Ctrough of anti-HER3-ac-DXd, Part 1: Ctrough of DXd in plasma, Part 1 and Part 2: Objective Response Rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 2: Percentage of Participants Who Experience an AE, Part 2: Percentage of Participants Who Discontinue Study Treatment Due to an AE, Part 1 and Part 2: Disease Control Rate (DCR), Part 1 and Part 2: Time to Response (TTR), Part 1 and Part 2: Duration of Response (DOR), Part 1 and Part 2: Progressive-free Survival (PFS), Part 1 and Part 2: Overall Survival (OS), Part 2: AUC of total anti-HER3 antibody LC-MS in plasma, Part 2: AUC of anti-HER3-ac-DXd in plasma, Part 2: AUC of DXd in plasma, Part 2: Cmax of anti-HER3 antibody LC-MS in plasma, Part 2: Cmax of anti-HER3-ac-DXd in plasma, Part 2: Cmax of DXd in plasma, Part 2: Ctrough of anti-HER3 antibody LC-MS in plasma, Part 2: Ctrough of anti-HER3-ac-DXd in plasma, Part 2: Ctrough of DXd in plasma | — |
Countries
Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Slovakia, Spain, Sweden