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Anti-GD2 ADC M3554 in Advanced Solid Tumors

NCT06641908 · EMD Serono
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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
About this study
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 criteria
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 design
Enrollment target: 52 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-11-08
Estimated completion: 2027-04-16
Last updated: 2026-04-15
Interventions
Drug: M3554
Primary outcomes
  • Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) (up to 4 months)
Sponsor
EMD Serono Research & Development Institute, Inc. · industry
With: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Contacts & investigators
ContactUS Medical Information · contact · eMediUSA@emdserono.com · 888-275-7376
ContactCommunication Center · contact · service@emdgroup.com · +49 6151 72 5200
InvestigatorMedical Responsible · study_director, EMD Serono Research & Development Institute, Inc.
All locations (11)
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York - Memorial Sloan Kettering Cancer Center (CC)- WestcWithdrawn
New York, New York, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, 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 MedicaleRecruiting
Lyon, France
Centre Antoine Lacassagne - Service d'Hématologie OncologieRecruiting
Nice, France
National Cancer Center HospitalRecruiting
Chūōku, Japan
Universitaetsspital Zuerich - Klinik fuer NeurologieRecruiting
Zurich, Switzerland
Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey)Recruiting
Sutton, Surrey, United Kingdom