A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)
Phase 1/2
50
about 5.6 years
0.0833333333333333–17
17 sites in CA, CO, CT +13
What this study is about
This trial is testing a treatment called patritumab deruxtecan, an antibody-drug conjugate, in children with relapsed or refractory solid tumors like hepatoblastoma or rhabdomyosarcoma. The goal is to learn about the safety and how the treatment works in these young patients.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive Patritumab Deruxtecan
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Part 1 and Part 2: Objective Response Rate (ORR), Part 1: AUC of DXd in plasma, Part 1: AUC of anti-HER3 antibody-conjugated DXd (anti-HER3-ac-DXd) in plasma, Part 1: Area Under the Curve (AUC) of total anti-HER3 antibody liquid chromatography-mass spectrometry (LC-MS) in plasma, Part 1: Cmax of DXd in plasma, Part 1: Cmax of anti-HER3-ac-DXd in plasma, Part 1: Maximum Concentration (Cmax) of anti-HER3 antibody LC-MS in plasma, Part 1: Percentage of Participants Who Discontinue Study Treatment Due to an AE
Secondary: Part 1 and Part 2: Disease Control Rate (DCR), Part 1 and Part 2: Duration of Response (DOR), Part 1 and Part 2: Overall Survival (OS), Part 1 and Part 2: Progression-free Survival (PFS), Part 2: AUC of DXd in plasma, Part 2: AUC of anti-HER3-ac-DXd in plasma, Part 2: AUC of total anti-HER3 antibody LC-MS in plasma, Part 2: Cmax of DXd in plasma
Oncology