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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

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518771-66-00
Acronym
MK-9999-01C
Enrollment
31
Registered
2025-06-03
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatoblastoma, Rhabdomyosarcoma

Brief summary

Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs), Part 1: Percentage of Participants Who Experience an Adverse Event (AE), Part 1: Percentage of Participants Who Discontinue Study Treatment Due to an AE, Part 1: Area Under the Curve (AUC) of total anti-HER3 antibody liquid chromatography-mass spectrometry (LC-MS) in plasma, Part 1: AUC of anti-HER3 antibody-conjugated DXd (anti-HER3-ac-DXd) in plasma, Part 1: AUC of DXd in plasma, Part 1: Maximum Concentration (Cmax) of anti-HER3 antibody LC-MS in plasma, Part 1: Cmax of anti-HER3-ac-DXd in plasma, Part 1: Cmax of DXd in plasma, Part 1: Concentration Immediately Before the Next Dose is Administered (Ctrough) of anti-HER3 antibody LC-MS in plasma, Part 1: Ctrough of anti-HER3-ac-DXd, Part 1: Ctrough of DXd in plasma, Part 1 and Part 2: Objective Response Rate (ORR)

Detailed description

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), Part 1 and Part 2: Time to Response (TTR), Part 1 and Part 2: Duration of Response (DOR), Part 1 and Part 2: Progressive-free Survival (PFS), Part 1 and Part 2: Overall Survival (OS), Part 2: AUC of total anti-HER3 antibody LC-MS in plasma, Part 2: AUC of anti-HER3-ac-DXd in plasma, Part 2: AUC of DXd in plasma, Part 2: Cmax of anti-HER3 antibody LC-MS in plasma, Part 2: Cmax of anti-HER3-ac-DXd in plasma, Part 2: Cmax of DXd in plasma, Part 2: Ctrough of anti-HER3 antibody LC-MS in plasma, Part 2: Ctrough of anti-HER3-ac-DXd in plasma, Part 2: Ctrough of DXd in plasma

Interventions

DRUG-
DRUGDEXAMETHASONE

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs), Part 1: Percentage of Participants Who Experience an Adverse Event (AE), Part 1: Percentage of Participants Who Discontinue Study Treatment Due to an AE, Part 1: Area Under the Curve (AUC) of total anti-HER3 antibody liquid chromatography-mass spectrometry (LC-MS) in plasma, Part 1: AUC of anti-HER3 antibody-conjugated DXd (anti-HER3-ac-DXd) in plasma, Part 1: AUC of DXd in plasma, Part 1: Maximum Concentration (Cmax) of anti-HER3 antibody LC-MS in plasma, Part 1: Cmax of anti-HER3-ac-DXd in plasma, Part 1: Cmax of DXd in plasma, Part 1: Concentration Immediately Before the Next Dose is Administered (Ctrough) of anti-HER3 antibody LC-MS in plasma, Part 1: Ctrough of anti-HER3-ac-DXd, Part 1: Ctrough of DXd in plasma, Part 1 and Part 2: Objective Response Rate (ORR)

Secondary

MeasureTime frame
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), Part 1 and Part 2: Time to Response (TTR), Part 1 and Part 2: Duration of Response (DOR), Part 1 and Part 2: Progressive-free Survival (PFS), Part 1 and Part 2: Overall Survival (OS), Part 2: AUC of total anti-HER3 antibody LC-MS in plasma, Part 2: AUC of anti-HER3-ac-DXd in plasma, Part 2: AUC of DXd in plasma, Part 2: Cmax of anti-HER3 antibody LC-MS in plasma, Part 2: Cmax of anti-HER3-ac-DXd in plasma, Part 2: Cmax of DXd in plasma, Part 2: Ctrough of anti-HER3 antibody LC-MS in plasma, Part 2: Ctrough of anti-HER3-ac-DXd in plasma, Part 2: Ctrough of DXd in plasma

Countries

Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026