Hematologic Malignancies or Solid Tumors in Pediatric and Young Adults
Conditions
Brief summary
Part 1: Area Under the Curve (AUC), Part 1: Maximum Concentration (Cmax), Part 1: Concentration in the Blood Immediately Before the Next Dose (Ctrough), Part 1: Number of Participants Who Experience Dose-limiting Toxicities (DLTs), Parts 1 and 2: Number of Participants Who Report at Least 1 Adverse Event (AE), Parts 1 and 2 : Number of Participants Who Discontinue Study Drug Due to an AE, Parts 1 and 2: Objective Response Rate (ORR) per Lugano Response Criteria by Blinded Independent Central Review (BICR), Parts 1 and 2: ORR per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator
Detailed description
Parts 1 and 2: ORR per Lugano Response Criteria by Investigator, Parts 1 and 2: Disease Control Rate (DCR) per Lugano Response Criteria by BICR, Parts 1 and 2: DCR per RECIST 1.1 by Investigator, Parts 1 and 2: Duration of response (DOR) per Lugano Response Criteria by BICR, Parts 1 and 2: DOR per RECIST 1.1 by Investigator, Parts 1 and 2: Progression Free Survival (PFS) per Lugano Response Criteria by BICR, Parts 1 and 2: PFS per RECIST 1.1 by Investigator, Parts 1 and 2: Overall Survival (OS), Part 2: Area Under the Curve (AUC), Part 2: Maximum Concentration (Cmax), Part 2: Concentration in the Blood Immediately Before the Next Dose (Ctrough), Parts 1 and 2: Antidrug Antibody (ADA) Levels, Parts and 2: Biomarkers for Classical Hodgkin Lymphoma (cHL)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Area Under the Curve (AUC), Part 1: Maximum Concentration (Cmax), Part 1: Concentration in the Blood Immediately Before the Next Dose (Ctrough), Part 1: Number of Participants Who Experience Dose-limiting Toxicities (DLTs), Parts 1 and 2: Number of Participants Who Report at Least 1 Adverse Event (AE), Parts 1 and 2 : Number of Participants Who Discontinue Study Drug Due to an AE, Parts 1 and 2: Objective Response Rate (ORR) per Lugano Response Criteria by Blinded Independent Central Review (BICR), Parts 1 and 2: ORR per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator | — |
Secondary
| Measure | Time frame |
|---|---|
| Parts 1 and 2: ORR per Lugano Response Criteria by Investigator, Parts 1 and 2: Disease Control Rate (DCR) per Lugano Response Criteria by BICR, Parts 1 and 2: DCR per RECIST 1.1 by Investigator, Parts 1 and 2: Duration of response (DOR) per Lugano Response Criteria by BICR, Parts 1 and 2: DOR per RECIST 1.1 by Investigator, Parts 1 and 2: Progression Free Survival (PFS) per Lugano Response Criteria by BICR, Parts 1 and 2: PFS per RECIST 1.1 by Investigator, Parts 1 and 2: Overall Survival (OS), Part 2: Area Under the Curve (AUC), Part 2: Maximum Concentration (Cmax), Part 2: Concentration in the Blood Immediately Before the Next Dose (Ctrough), Parts 1 and 2: Antidrug Antibody (ADA) Levels, Parts and 2: Biomarkers for Classical Hodgkin Lymphoma (cHL) | — |
Countries
Denmark