A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)
LIGHTBEAM-U01 Substudy 01C: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors
Sponsor: Merck Sharp & Dohme LLC + Daiichi Sankyo
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Time frame: Cycle 1 (up to approximately 21 days); each cycle is 21 days
Part 1: Percentage of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 5 years
Part 1: Percentage of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 5 years
Part 1: Area Under the Curve (AUC) of total anti-HER3 antibody liquid chromatography-mass spectrometry (LC-MS) in plasma
Time frame: At designated timepoints (up to approximately 5 years)
Secondary Endpoints
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)
Eligibility Criteria
The main inclusion criteria include but are not limited to the following: * Has one of the following histologically confirmed advanced or metastatic solid tumors: Rhabdomyosarcoma (RMS), or Hepatoblastoma * Has progressed after at least 1 prior systemic treatment for RMS or hepatoblastoma and who has no satisfactory alternative treatment option (ie, is ineligible for other standard treatment regimens) * Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have Grade ≤2 neuropathy are eligible. Participants with Grade ≤2 alopecia are also eligible * Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load * Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV v…
Read full criteria on CT.gov →✦ Analyst Commentary
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