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LIGHTBEAM-U01-Substudy 01A: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants with Hematologic Malignancies or Solid Tumors.

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507178-41-00
Acronym
MK-9999-01A
Enrollment
50
Registered
2024-04-15
Start date
2024-11-07
Completion date
Unknown
Last updated
2026-01-22

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

Conditions

Hematologic Malignancies or Solid Tumors in Pediatric and Young Adults

Brief summary

Part 1: Number of Participants from 1 to <18 years of Age Who Experience a Dose-Limiting Toxicity (DLT), Part 1: Number of Participants from 1 to <18 years of Age Who Experience One or More Adverse Events (AEs), Part 1: Number of Participants from 1 to <18 years of Age Who Discontinue Study Treatment Due to AEs, Part 1: Number of Participants from 1 to <18 years of Age Who Receive Dose Modification Due to AEs, Part 1 and Part 2: Objective Response (OR) for Participants with B-Cell Acute Lymphoblastic Leukemia (B-ALL), Part 1 and Part 2: OR for Participants with Diffuse Large B-Cell Lymphoma (DLBCL)/Burkitt Lymphoma, Neuroblastoma, and Ewing Sarcoma

Detailed description

Part 1 and Part 2: Area Under the Curve (AUC) of Total Antibody, Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of Total Antibody, Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of Total Antibody, Part 1 and Part 2: Apparent Terminal Half-life (t1/2) of Total Antibody, Part 1 and Part 2: AUC of Antibody-Drug Conjugate (ADC), Part 1 and Part 2: Cmax of Antibody-Drug Conjugate (ADC), Part 1 and Part 2: Ctrough of Antibody-Drug Conjugate (ADC), Part 1 and Part 2: t1/2 of Antibody-Drug Conjugate (ADC), Part 1 and Part 2: AUC of Monomethyl Auristatin E (MMAE), Part 1 and Part 2: Cmax of Monomethyl Auristatin E (MMAE), Part 1 and Part 2: Ctrough of Monomethyl Auristatin E (MMAE), Part 1 and Part 2: t1/2 of Monomethyl Auristatin E (MMAE), Part 2: Number of Participants Who Experience One or More Adverse Events (AEs), Part 2: Number of Participants Who Discontinue Study Treatment Due to AEs, Part 2: Number of Participants Who Receive Dose Modification Due to AEs, Part 1 and Part 2: Incidence of Antidrug antibodies (ADAs) to Zilovertamab Vedotin, Part 1 and Part 2: Duration of Response (DOR), Part 1 and Part 2: Percentage of Participants with DLBCL/Burkitt Lymphoma Who Receive Stem Cell Transplant (SCT), Part 1 and Part 2: Percentage of Participants with B-ALL Who Receive SCT, Part 1 and Part 2: Percentage of Participants with B-ALL Who Receive Chimeric Antigen Receptor T (CAR-T)

Interventions

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Part 1: Number of Participants from 1 to <18 years of Age Who Experience a Dose-Limiting Toxicity (DLT), Part 1: Number of Participants from 1 to <18 years of Age Who Experience One or More Adverse Events (AEs), Part 1: Number of Participants from 1 to <18 years of Age Who Discontinue Study Treatment Due to AEs, Part 1: Number of Participants from 1 to <18 years of Age Who Receive Dose Modification Due to AEs, Part 1 and Part 2: Objective Response (OR) for Participants with B-Cell Acute Lymphoblastic Leukemia (B-ALL), Part 1 and Part 2: OR for Participants with Diffuse Large B-Cell Lymphoma (DLBCL)/Burkitt Lymphoma, Neuroblastoma, and Ewing Sarcoma

Secondary

MeasureTime frame
Part 1 and Part 2: Area Under the Curve (AUC) of Total Antibody, Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of Total Antibody, Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of Total Antibody, Part 1 and Part 2: Apparent Terminal Half-life (t1/2) of Total Antibody, Part 1 and Part 2: AUC of Antibody-Drug Conjugate (ADC), Part 1 and Part 2: Cmax of Antibody-Drug Conjugate (ADC), Part 1 and Part 2: Ctrough of Antibody-Drug Conjugate (ADC), Part 1 and Part 2: t1/2 of Antibody-Drug Conjugate (ADC), Part 1 and Part 2: AUC of Monomethyl Auristatin E (MMAE), Part 1 and Part 2: Cmax of Monomethyl Auristatin E (MMAE), Part 1 and Part 2: Ctrough of Monomethyl Auristatin E (MMAE), Part 1 and Part 2: t1/2 of Monomethyl Auristatin E (MMAE), Part 2: Number of Participants Who Experience One or More Adverse Events (AEs), Part 2: Number of Participants Who Discontinue Study Treatment Due to AEs, Part 2: Number of Participants Who Receive Dose Modification Due to AEs, Part 1 and P

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