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Looking for participantsPhase1

Anti-GD2 ADC M3554 in Advanced Solid Tumors

Sponsor: EMD Serono Research & Development Institute, Inc.

NCT ID: NCT06641908

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
M3554 (drug)
How long the study runs
Study runs about 29 months (dates as stated)
About the drug or intervention
M3554 — drug: 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).
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
65
Started
2024-11-08
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for advanced solid tumor
  • • Phase1 - 65 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with advanced solid tumor

Where?

  • • Sutton - Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Advanced Solid Tumor

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ of anthracycline-containing systemic therapy f
  • ✓ of therapy (including radiotherapy +/- temozolomide

What the study is looking for

  • ✓activity scale Performance Status (ECOG PS) below or equal to 1
  • ✓Participants with adequate blood, liver and kidney function as defined in protocol
  • ✓Other protocol defined inclusion criteria could apply

Who cannot take part

  • ✗STS only: Participants with history of brain metastasis, leptomeningeal metastasis, or participants with spinal cord...
  • ✗Other protocol defined exclusion criteria could apply.
See the full 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 Is This Study? (1 UK site)

Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey)

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Barnett

rsc-tr.ResearchAndDevelopment@nhs.net01483 688600

How to Get in Touch

US Medical Information

Sponsor contact

CONTACT

888-275-7376 eMediUSA@emdserono.com

Communication Center

Sponsor contact

CONTACT

+49 6151 72 5200 service@emdgroup.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10