M3554 treatment for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• 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 Antoine Lacassagne - Service d'Hématologie Oncologie
  Nice, France Recruiting

Study contacts

• Study coordinator: US Medical Information
• Email: eMediUSA@emdserono.com
• Phone: 888-275-7376

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.