Who may be eligible for the Anti-GD2 ADC M3554 in Advanced Solid Tumors trial?

Inclusion Criteria: * Escalation A: participants with documented histopathological diagnosis of locally advanced or metastatic STS with unresectable disease that has progressed after at least one prior line of anthracycline-containing systemic therapy for the locally advanced/metastatic setting. * Participants with resectable locally advanced or metastatic disease, who had surgery before study entry will be allowed in the trial if there is residual disease after surgery and if the surgery was performed at least 4 weeks before first dose of study intervention. * Escalation B: participants with documented histopathological diagnosis of glioblastoma, IDH-wildtype, who have progressed after ONLY one prior line of therapy (including radiotherapy +/- temozolomide, depending on the O\^6-methylguanine-DNA methyltransferase \[MGMT\] status) and relapsing at least 3 months after the end of the radiotherapy treatment. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1 * Participants with adequate hematologic, hepatic and renal function as defined in protocol * Other protocol defined inclusion criteria could apply * Exclusion Criteria: * Participant has a history of malignancy other than STS or glioblastoma (depending on the escalation/expansion cohort) within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, is considered cured with minimal risk of recurrence within 3 years). * STS only: Participants with history of brain metastasis, leptomeningeal metastasis, or participants with spinal cord compression * Other protocol defined exclusion criteria could apply.

ClinicalTrials.gov record NCT06641908

Anti-GD2 ADC M3554 in Advanced Solid Tumors

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 16, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.

Age18 years old and older

SexAll

LocationBelgium, France, Japan, Switzerland, United Kingdom, United States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This first‑in‑human Phase 1 study gives the drug M3554 to people with advanced solid tumors, with specific focus on soft tissue sarcoma and IDH‑wildtype glioblastoma. It uses sequential dose escalation to find recommended dose(s) and to evaluate safety and early signs of antitumor activity. The planned on‑study assessment period is about 4 months per participant.

What it is studying. The study is trying to find safe and recommended dose(s) of M3554, to record side effects and dose‑limiting toxicities, and to look for early evidence of tumor response. It also measures how the drug behaves in the body (pharmacokinetics) and tracks certain cardiac and tumor‑response outcomes.

What the researchers hope to learn. To determine dose‑limiting toxicities and a recommended dose(s) for M3554; to further evaluate safety and adverse events; to characterize pharmacokinetics; and to collect preliminary measures of tumor response, duration of response, progression‑free survival, and QTc interval changes.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: M3554

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

Escalation A: participants with documented histopathological diagnosis of locally advanced or metastatic STS with unresectable disease that has progressed after at least one prior line of anthracycline-containing systemic therapy for the locally advanced/metastatic setting.
Participants with resectable locally advanced or metastatic disease, who had surgery before study entry will be allowed in the trial if there is residual disease after surgery and if the surgery was performed at least 4 weeks before first dose of study intervention.
Escalation B: participants with documented histopathological diagnosis of glioblastoma, IDH-wildtype, who have progressed after ONLY one prior line of therapy (including radiotherapy +/- temozolomide, depending on the O\^6-methylguanine-DNA methyltransferase [MGMT] status) and relapsing at least 3 months after the end of the radiotherapy treatment.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1
Participants with adequate hematologic, hepatic and renal function as defined in protocol
Other protocol defined inclusion criteria could apply

Exclusion criteria

Participant has a history of malignancy other than STS or glioblastoma (depending on the escalation/expansion cohort) within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, is considered cured with minimal risk of recurrence within 3 years).
STS only: Participants with history of brain metastasis, leptomeningeal metastasis, or participants with spinal cord compression
Other protocol defined exclusion criteria could apply.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You would receive the experimental drug M3554 in repeated 21-day treatment cycles while doses are increased to find a safe/recommended dose. Participation lasts about 4 months and includes regular clinic visits for safety checks and reporting side effects, blood draws to measure drug levels (pharmacokinetics) on specified cycle days, and heart monitoring for QTc changes before and after dosing on defined days. Tumor status will be assessed using standard criteria (RECIST 1.1 for most tumors or RANO 2.0 for brain tumors) at planned time points.

How the study is structured. First‑in‑human, open‑label Phase 1 trial with two sequential dose‑escalation parts (Escalation A for soft tissue sarcoma; Escalation B for IDH‑wildtype glioblastoma). All participants receive M3554 monotherapy; doses are increased across participants until a maximum tolerated dose or a recommended dose is determined. Treatment is given in repeated 21‑day cycles with safety, pharmacokinetic, and tumor‑response assessments conducted during approximately four months of planned follow‑up.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Advanced Solid Tumor. Does it apply to my diagnosis?
This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
The listed sites are in Belgium, France, Japan, Switzerland, United Kingdom, United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on Gaucher disease

Clinical trials64 trials listed for Gaucher diseaseEvery trial the registry lists for Gaucher disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Gaucher disease researchLatest monthly update: September 2026. Includes: Platelet release. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Nov 8, 2024
Primary completion: Apr 16, 2027 (estimated)
Study completion: Apr 16, 2027 (estimated)
Target enrollment: 65 participants (estimated)
Last updated on registry: Oct 7, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

US Medical Information 📞 888-275-7376 ✉ eMediUSA@emdserono.com
Communication Center 📞 +49 6151 72 5200 ✉ service@emdgroup.com

Participating sites (11)

Filter by country:

Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, 02215 · United States
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York - Memorial Sloan Kettering Cancer Center (CC)- WestcWithdrawn
New York, New York, 10022 · United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, 77030 · United States
UZ LeuvenRecruiting
Leuven · Belgium
Institut Bergonié - Service d'Oncologie MédicaleRecruiting
Bordeaux · France
Centre Oscar Lambret - cancerologie generaleRecruiting
Lille · France
Centre Leon Berard - Service d'Oncologie MedicaleActive Not Recruiting
Lyon · France
Centre Antoine Lacassagne - Service d'Hématologie OncologieRecruiting
Nice · France
National Cancer Center HospitalRecruiting
Chūōku · Japan
Universitaetsspital Zuerich - Klinik fuer NeurologieRecruiting
Zurich, 8091 · Switzerland

Terms used on this page · explanations by MedicalUpdates.ai

line of therapy: Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
Performance Status: A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
inclusion criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
cohort: A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
exclusion criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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