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RECRUITING
NCT06641908
PHASE1

Anti-GD2 ADC M3554 in Advanced Solid Tumors

Sponsor: EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to establish the recommended doses and further evaluate the safety and preliminary antitumor activity of M3554 in participants with soft tissue sarcoma (STS) and glioblastoma, IDH-wildtype. Study details include: Study Duration per participant: Approximately 4 months

Official 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2024-11-08

Completion Date

2027-04-16

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

DRUG

M3554

M3554 will be administered at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose is determined in participants with STS (dose escalation A) and glioblastoma and IDH wildtype (dose escalation B).

Locations (11)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York - Memorial Sloan Kettering Cancer Center (CC)- Westc

New York, New York, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

UZ Leuven

Leuven, Belgium

Institut Bergonié - Service d'Oncologie Médicale

Bordeaux, France

Centre Oscar Lambret - cancerologie generale

Lille, France

Centre Leon Berard - Service d'Oncologie Medicale

Lyon, France

Centre Antoine Lacassagne - Service d'Hématologie Oncologie

Nice, France

National Cancer Center Hospital

Chūōku, Japan

Universitaetsspital Zuerich - Klinik fuer Neurologie

Zurich, Switzerland

Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey)

Sutton, Surrey, United Kingdom