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OncoMatch/Clinical Trials/NCT06641908

Anti-GD2 ADC M3554 in Advanced Solid Tumors

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

Is NCT06641908 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies M3554 for advanced solid tumor.

Phase 1RecruitingEMD Serono Research & Development Institute, Inc.NCT06641908Data as of Oct 2026Location: International · 6 countries

Treatment: M3554 — 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

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Extracted eligibility criteria

Treatments studied

Other

M3554

Cancer type

Tumor Agnostic

Glioblastoma

Sarcoma

Biomarker criteria

Required: IDH1 wild-type

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: anthracycline-containing systemic therapy — locally advanced/metastatic STS

progressed after at least one prior line of anthracycline-containing systemic therapy for the locally advanced/metastatic setting

Must have received: systemic therapy — glioblastoma

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)

Lab requirements

Blood counts

Kidney function

Liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Dana-Farber Cancer Institute · Boston, Massachusetts
  • Memorial Sloan-Kettering Cancer Center (MSKCC) - New York - Memorial Sloan Kettering Cancer Center (CC)- Westc · New York, New York
  • The University of Texas MD Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06641908 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received anthracycline-containing systemic therapy and systemic therapy.

Does this trial require IDH1?

Yes, IDH1 wild-type is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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