NCT06641908RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- First submitted
- 9 Oct 2024
- Start date
- 8 Nov 2024
- Primary completion date
- 16 Apr 2027
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Diseases
- Glioblastoma, Sarcoma
- NCT number
- NCT06641908
- EU CT number
- 2024-513687-26-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 65
- From 8 Nov 2024 to the primary completion date, 16 Apr 2027
- 11 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Universitaetsspital Zuerich - Klinik fuer Neurologie Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| Institut Bergonié - Service d'Oncologie Médicale Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Oscar Lambret - cancerologie generale Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Centre Leon Berard - Service d'Oncologie Medicale Coordinator of this site? Confirm its status | Lyon | France | Active, not recruiting |
| Centre Antoine Lacassagne - Service d'Hématologie Oncologie Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey) Coordinator of this site? Confirm its status | Sutton | United Kingdom | Recruiting |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chūōku | Japan | Recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center (MSKCC) - New York - Memorial Sloan Kettering Cancer Center (CC)- Westc Coordinator of this site? Confirm its status | New York | United States | Withdrawn |
This page is information, not medical advice. Discuss any trial with your doctor.