Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06641908

Anti-GD2 ADC M3554 in Advanced Solid Tumors

Led by EMD Serono Research & Development Institute, Inc. · Updated on 2026-05-08

52

Participants Needed

11

Research Sites

127 weeks

Total Duration

On this page

Sponsors

E

EMD Serono Research & Development Institute, Inc.

Lead Sponsor

M

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Anti-GD2 ADC M3554 in Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants with locally advanced or metastatic soft tissue sarcoma (STS) that has progressed after at least one prior anthracycline-containing systemic therapy
  • Participants with resectable STS who had surgery at least 4 weeks before study start and have residual disease
  • Participants with glioblastoma, IDH-wildtype, who progressed after only one prior therapy and relapsed at least 3 months after radiotherapy
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  • Adequate blood, liver, and kidney function as defined by the study protocol
  • Other inclusion criteria as defined by the protocol
Not Eligible

You will not qualify if you...

  • History of malignancy other than STS or glioblastoma within 3 years before enrollment, except certain skin cancers, cervical carcinoma in situ, benign prostate conditions, or malignancies considered cured with minimal recurrence risk
  • For STS participants only: history of brain metastasis, leptomeningeal metastasis, or spinal cord compression
  • Other exclusion criteria as defined by the study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

2

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

New York, New York, United States, 10022

Withdrawn

3

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

4

UZ Leuven

Leuven, Belgium

Actively Recruiting

5

Institut Bergonié - Service d'Oncologie Médicale

Bordeaux, France

Actively Recruiting

6

Centre Oscar Lambret - cancerologie generale

Lille, France

Actively Recruiting

7

Centre Leon Berard - Service d'Oncologie Medicale

Lyon, France

Actively Recruiting

8

Centre Antoine Lacassagne - Service d'Hématologie Oncologie

Nice, France

Actively Recruiting

9

National Cancer Center Hospital

Chūōku, Japan

Actively Recruiting

10

Universitaetsspital Zuerich - Klinik fuer Neurologie

Zurich, Switzerland, 8091

Actively Recruiting

11

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

Sutton, Surrey, United Kingdom, SM2 5PT

Actively Recruiting

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Research Team

U

US Medical Information

CONTACT

C

Communication Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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