MS201460_0001 Anti-GD2 ADC M3554 in Advanced Solid Tumors

• Research type

  Research Study

• Full title

  A Phase 1, Two-Part, Multicenter, Open-Label First in Human Study of anti-GD2 Antibody Drug Conjugate M3554 in Participants with Advanced Solid Tumors

• IRAS ID

  1011822

• Contact name

  Communication Center Merck KGaA

• Contact email

  CTIS-GRA@merckgroup.com

• Sponsor organisation

  Merck Healthcare KGaA

• Research summary

  The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary clinical activity of M3554 in patients with soft tissue sarcoma (STS) and glioblastoma (GBM) IDH-wildtype.
  
  M3554 is an investigational drug that is being evaluated for the treatment of patients with advanced solid tumours in this first in human - Phase I study. Participants will be treated until disease progression, toxicity, death, discontinuation, or End of Study.
  
  The screening period takes place up to 28 days prior to the administration of the first dose of the study drug. Participants will enter either Escalation A or Escalation B depending on tumour type (STS or GBM). The treatment period will last for approximately 4 treatment cycles and will depend on response to the study drug. The study drug will be given in consecutive 21-days cycles (every 3 weeks) as an intravenous infusion on Day 1 of each cycle. An End of Treatment Visit and Safety Follow-up/Discontinuation Visit are scheduled after the treatment period.
  
  This research study will include 2 parts investigating the study drug in patients with locally advanced/metastatic soft tissue sarcoma and glioblastoma. Phase 1a: Dose Escalation (starting with a small amount of study drug and then slowly increasing it over time) to establish the recommended doses and Phase 1b: Dose Expansion continuing to test a study drug at a certain dose level to learn more about how it works and how well patients tolerate it. A total of approximately 160 participants are planned to be enrolled across 6 countries out of which: 30 participants in Phase 1a dose escalation for STS; 20 participants in Phase 1a dose escalation for glioblastoma; 80 participants in Phase 1b dose expansion for STS and 30 participants in Phase 1b dose expansion for glioblastoma.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  25/LO/0450

• Date of REC Opinion

  31 Jul 2025

• REC opinion

  Further Information Favourable Opinion