Back to search results

M3554 for Advanced Solid Tumors

This study is testing a new drug called M3554 in people with advanced solid tumors, specifically soft tissue sarcoma (STS) and a type of brain tumor called glioblastoma. The main goal is to find a safe and effective dose of M3554 and to see if it has any anti-tumor effects. You might be able to join if you are 18 or older and have locally advanced or metastatic STS that has worsened after at least one previous treatment. The study is currently unclear about its recruitment status.

Study design
This is an interventional study planning to enroll 52 participants. It will involve increasing the dose of M3554 until the highest safe dose is found.
What's involved
Your participation in this study would last approximately 4 months.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects and other events for up to 4 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06641908

Anti-GD2 ADC M3554 in Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
EMD Serono Research & Development Institute, Inc.
~52 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:M3554

At a glance

Recruiting sites
9 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)
Measured over up to 4 months

Conditions

Advanced Solid Tumor

Explore related trials

GlioblastomaSoft Tissue SarcomaIDH1 wt Allele

Where it's being run

11 sites across 8 states
France4
Massachusetts1
New York1
Texas1
Belgium1
Japan1
Switzerland1
Surrey1

Study leadership

  • Medical Responsible · STUDY_DIRECTOR · EMD Serono Research & Development Institute, Inc.

Who to contact

US Medical Information
[email protected]
888-275-7376
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)up to 4 months