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NCT06641908Recruiting

Anti-GD2 ADC M3554 in Advanced Solid Tumors

Official recordSimplified version

Summary

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

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.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
Phase 1
Study type
Interventional
Countries
Switzerland, France, United States, Belgium, Japan, United Kingdom
Sponsor
EMD Serono Research & Development Institute, Inc.(Industry)
Protocol no.
MS201460_0001
Conditions
Advanced Solid Tumor
Interventions
Drug

Treatments studied

  • M3554

Collaborators

Merck KGaA, Darmstadt, Germany

Locations · 9

  • Zurich, SwitzerlandUniversitaetsspital Zuerich - Klinik fuer NeurologieRecruiting at this site
  • Bordeaux, FranceInstitut Bergonié - Service d'Oncologie MédicaleRecruiting at this site
  • Lille, FranceCentre Oscar Lambret - cancerologie generaleRecruiting at this site
  • Nice, FranceCentre Antoine Lacassagne - Service d'Hématologie OncologieRecruiting at this site
  • Boston, United StatesDana-Farber Cancer InstituteRecruiting at this site
  • Houston, United StatesThe University of Texas MD Anderson Cancer CenterRecruiting at this site
  • Leuven, BelgiumUZ LeuvenRecruiting at this site
  • Chūōku, JapanNational Cancer Center HospitalRecruiting at this site
  • Sutton, United KingdomRoyal Marsden Hospital-Sutton - Dept of Oncology (Surrey)Recruiting at this site

In total, worldwide, 9 of the 11 sites listed in the registry are recruiting; the other 2 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: October 7, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

Other identifiers

  • 2024-513687-26-00 · other identifier
  • jRCT2031240430 · other identifier

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.