M3554 treatment for 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
PHASE1 · EMD Serono · NCT06641908
This study is testing a new treatment called M3554 to see if it can help people with advanced solid tumors, like certain types of sarcomas and glioblastomas, who haven't had success with other treatments.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | EMD Serono (industry) |
| Locations | 11 sites (Boston, Massachusetts and 10 other locations) |
| Trial ID | NCT06641908 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of M3554, an anti-GD2 antibody-drug conjugate, in patients with advanced solid tumors, specifically soft tissue sarcomas and glioblastoma that is IDH-wildtype. The trial aims to determine the recommended doses of M3554 and assess its preliminary antitumor activity in participants who have not responded to previous treatments. Participants will be monitored over approximately four months to gather data on the drug's effects and safety profile.
Who should consider this trial
Good fit: Ideal candidates include individuals with advanced soft tissue sarcomas or glioblastoma who have progressed after at least one prior line of systemic therapy.
Not a fit: Patients with early-stage tumors or those who have not received prior systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new targeted therapy option for patients with advanced solid tumors.
How similar studies have performed: Other studies using targeted therapies for similar conditions have shown promise, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts and 10 other locations
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
- Memorial Sloan-Kettering Cancer Center (MSKCC) - New York - Memorial Sloan Kettering Cancer Center (CC)- Westc — New York, New York, United States (WITHDRAWN)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- UZ Leuven — Leuven, Belgium (RECRUITING)
- Institut Bergonié - Service d'Oncologie Médicale — Bordeaux, France (RECRUITING)
- Centre Oscar Lambret - cancerologie generale — Lille, France (RECRUITING)
- Centre Leon Berard - Service d'Oncologie Medicale — Lyon, France (RECRUITING)
- Centre Antoine Lacassagne - Service d'Hématologie Oncologie — Nice, France (RECRUITING)
- National Cancer Center Hospital — Chūōku, Japan (RECRUITING)
- Universitaetsspital Zuerich - Klinik fuer Neurologie — Zurich, Switzerland (RECRUITING)
- Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey) — Sutton, Surrey, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: US Medical Information
- Email: eMediUSA@emdserono.com
- Phone: 888-275-7376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Solid Tumor, Glioblastoma, IDH-wildtype, Soft tissue sarcomas, GD2 prevalence, targeted therapy, TOP1 inhibitor, exatecan