A Study of Patritumab Deruxtecan in Pediatric Participant... | NCT06941272

NCT06941272

ID	Type	Description
MK-9999-01C	Other Identifier	MSD
LIGHTBEAM-U01	Other Identifier	MSD
U1111-1314-1866	Registry Identifier	UTN
2024-518771-66-00	Registry Identifier	EU CT

Status Module

Name	Class
Daiichi Sankyo	INDUSTRY

Description Module

Label	Type	Description	Intervention Names
Patritumab Deruxtecan	Experimental	Participants receive patritumab deruxtecan via IV infusion on Day 1 of each 3-week cycle until discontinuation or progression.	Biological: Patritumab Deruxtecan

Name	Type	Description	Arm Group Labels	Other Names
Patritumab Deruxtecan	Biological	IV Infusion	Patritumab Deruxtecan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)	A DLT is any of a prespecified list of adverse events (AEs) that occur during Cycle 1 (up to 21 days) if attributed to the study treatment and not attributed to any other clearly identifiable cause. The percentage of participants who experience DLTs will be reported. Each cycle is 21 days.	Cycle 1 (up to approximately 21 days); each cycle is 21 days
Part 1: Percentage of Participants Who Experience an Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience AEs will be reported.	Up to approximately 5 years
Part 1: Percentage of Participants Who Discontinue Study Treatment Due to an AE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.	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	Blood samples will be collected at specified intervals for the determination of AUC.	At designated timepoints (up to approximately 5 years)

Secondary Outcomes

Measure	Description	Time Frame
Part 2: Percentage of Participants Who Experience an AE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience AEs will be reported.

Eligibility Module

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 viral load is undetectable

The main exclusion criteria include but are not limited to the following:

Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis, and/or suspected ILD/pneumonitis that cannot be ruled out by standard diagnostic assessments
Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness
Has a history of solid organ transplant
Has a history of allogeneic stem cell transplant
Has clinically significant corneal disease
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis/leptomeningeal disease; participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks
Has uncontrolled or significant cardiovascular disorder
Has a history of clinically significant congenital cardiac syndrome
Has a history of human immunodeficiency virus (HIV) infection
Has a known additional malignancy that is progressing or has required active treatment within the past 1 year
Has an active infection requiring systemic therapy
Has concurrent active hepatitis B (HBsAg positive and/or detectable HBV deoxyribonucleic acid [DNA]) and HCV defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid [RNA]) infection
Has not adequately recovered from major surgery or have ongoing surgical complications

Label	URL
Merck Clinical Trials Information	View source
Plain Language Summary	View source