Neoplasm malignant
Conditions
Brief summary
Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience a Dose-limiting Toxicity (DLT), Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience One or More Adverse Events (AEs), Part 1: Number of Participants From ≥1 Month to <12 Years Who Discontinue Study Intervention Due to an AE, Part 1: Number of Participants From ≥1 Month to <12 Years Who Receive Dose Modifications Due to AEs, Part 1 and Part 2: Objective Response Rate (ORR) for Participants with neuroblastoma (NBL), rhabdomyosarcoma (RMS), and Wilms tumor (WT), Part 1 and Part 2: Disease Control Success at 4 Months (DCS-4) for Participants with osteosarcoma (OST)
Detailed description
Part 1 and Part 2: Duration of Response (DOR) For Participants With NBL, RMS, WT, or OST, Part 1 and Part 2: Disease Control Rate (DCR) For Participants With NBL, RMS, WT, or OST, Part 1 and Part 2: Time to Response (TTR) For Participants With NBL, RMS, WT, or OST, Part 1 and Part 2: Progression-free Survival (PFS) For Participants With NBL, RMS, WT, or OST, Part 1 and Part 2: ORR for Participants With OST, Part 1 and Part 2: Overall Survival (OS), Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Experience One or More AEs, Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Discontinue Study Treatment Due to an AE, Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Receive Dose modifications due to AEs, Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of Ifinatamab Deruxtecan (I-DXd), Part 1 and Part 2: Area Under the Concentration-Time Curve from Time 0 to the End of the Dosing Period (AUC-tau) of I-DXd, Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of I-DXd, Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of DXd, Part 1 and Part 2: Area Under the Concentration-Time Curve from Time 0 to the End of the Dosing Period (AUC-tau) of DXd, Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of DXd, Part 1 and Part 2: Number of Participants with Antidrug Antibodies (ADA) Against I-DXd
Interventions
DRUGIfinatamab Deruxtecan
Sponsors
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience a Dose-limiting Toxicity (DLT), Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience One or More Adverse Events (AEs), Part 1: Number of Participants From ≥1 Month to <12 Years Who Discontinue Study Intervention Due to an AE, Part 1: Number of Participants From ≥1 Month to <12 Years Who Receive Dose Modifications Due to AEs, Part 1 and Part 2: Objective Response Rate (ORR) for Participants with neuroblastoma (NBL), rhabdomyosarcoma (RMS), and Wilms tumor (WT), Part 1 and Part 2: Disease Control Success at 4 Months (DCS-4) for Participants with osteosarcoma (OST) | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 and Part 2: Duration of Response (DOR) For Participants With NBL, RMS, WT, or OST, Part 1 and Part 2: Disease Control Rate (DCR) For Participants With NBL, RMS, WT, or OST, Part 1 and Part 2: Time to Response (TTR) For Participants With NBL, RMS, WT, or OST, Part 1 and Part 2: Progression-free Survival (PFS) For Participants With NBL, RMS, WT, or OST, Part 1 and Part 2: ORR for Participants With OST, Part 1 and Part 2: Overall Survival (OS), Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Experience One or More AEs, Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Discontinue Study Treatment Due to an AE, Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Receive Dose modifications due to AEs, Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of Ifinatamab Deruxtecan (I-DXd), Part 1 and Part 2: Area Under the Concentration-Time Curve from Time 0 to the End of the Dosing Period (AUC-tau) of I-DXd, Part 1 and | — |
Outcome results
None listed