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RecruitingNCT06641908Updated Sep 22, 2026

Anti-GD2 ADC M3554 in Advanced Solid Tumors

A Phase 1 interventional study of M3554 in Advanced Solid Tumor, sponsored by EMD Serono Research & Development Institute, Inc.. Recruiting at 11 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by EMD Serono Research & Development Institute, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
65
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Advanced Solid Tumor

Keywords

  • Glioblastoma
  • IDH-wildtype
  • Soft tissue sarcomas
  • GD2 prevalence
  • targeted therapy
  • TOP1 inhibitor
  • exatecan
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

  • 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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
65 participants (estimated)

Study arms

  • Experimental
    Dose Escalation: M3554 Monotherapy

    Drug: M3554

Interventions

  • DrugM3554

    M3554 will be administered at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose is determined in participants with STS (dose escalation A) and glioblastoma and IDH wildtype (dose escalation B).

05

What researchers measure

Primary outcomes

  1. Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)

    Time frame: up to 4 months

Secondary outcomes

  1. Pharmacokinetic (PK) Plasma Concentrations of M3554

    Time frame: Cycle 1 Day 1 to Cycle 3 Day 15 and every second cycle from Cycle 4 (each cycle is of 21 days), assessed up to approximately 4 months

  2. Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 as Assessed by Investigator

    Time frame: Time from randomization to planned assessment at 4 months

  3. Duration of Response (DoR) According to RECIST Version 1.1 or RANO 2.0 as Assessed by Investigator

    Time frame: Time from randomization to planned assessment at 4 months

  4. Progression-free Survival (PFS) According to RECIST Version 1.1 or RANO 2.0 as Assessed by Investigator

    Time frame: Time from randomization to planned assessment at 4 months

  5. Change from Baseline in Corrected QT Interval (QTc) Interval

    Time frame: Pre-dose on Day 1 (baseline) up to 24 hours post-dose Day 1, Day 2, Day 5, Day 8 of Cycle 1 and Cycle 3 Day 1 (each Cycle is 21 days)

06

Study locations

9 of 11 sites recruiting
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
    Recruiting
  • Memorial Sloan-Kettering Cancer Center (MSKCC) - New York - Memorial Sloan Kettering Cancer Center (CC)- Westc
    New York, New York 10022, United States
    Withdrawn
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, 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
    Active, not recruiting
  • Centre Antoine Lacassagne - Service d'Hématologie Oncologie
    Nice, France
    Recruiting
  • National Cancer Center Hospital
    Chūōku, Japan
    Recruiting
  • Universitaetsspital Zuerich - Klinik fuer Neurologie
    Zurich, 8091, Switzerland
    Recruiting
  • Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey)
    Sutton, Surrey SM2 5PT, United Kingdom
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — IPD will not be shared for Phase I interventional or observational studies. Further information on how to request data can be found on our website bit.ly/IPD21.

08

Registry details

Key details

Study ID
NCT06641908
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany
Responsible party
Sponsor
First posted
Oct 15, 2024
Start date
Nov 8, 2024
Primary completion
Apr 16, 2027 (estimated)
Completion
Apr 16, 2027 (estimated)
Last update
Sep 22, 2026

Study contacts

US Medical Information
Contact
eMediUSA@emdserono.com
888-275-7376
Communication Center
Contact
service@emdgroup.com
+49 6151 72 5200
Medical Responsible
study director · EMD Serono Research & Development Institute, Inc.

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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