RecruitingPhase 1NCT06641908

Anti-GD2 ADC M3554 in Advanced Solid Tumors

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


Sponsor

EMD Serono Research & Development Institute, Inc.

Enrollment

52 participants

Start Date

Nov 8, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new antibody-drug conjugate (ADC) called M3554, which targets a protein called GD2 found on certain cancer cells, in people with advanced soft tissue sarcoma or glioblastoma (a type of brain cancer) that has not responded to prior treatments. **You may be eligible if...** - You have advanced soft tissue sarcoma that has progressed after at least one prior line of chemotherapy containing anthracycline drugs, OR - You have glioblastoma that has progressed after one prior treatment (radiation plus/minus chemotherapy) and it has been at least 3 months since radiation - Your general health and organ function meet protocol requirements (ECOG 0-1) **You may NOT be eligible if...** - You have had another cancer in the past 3 years (with some exceptions) - You have brain or spinal cord metastases (for the soft tissue sarcoma group) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGM3554

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06641908


Related Trials