Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 1interventionalRules rewrite

Phase 1: testing M3554 for Advanced Solid Tumor

This study wants to establish the recommended doses and further measure 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

Official registry: https://clinicaltrials.gov/study/NCT06641908 · EMD Serono Research & Development Institute, Inc. · enrollment listed as 65

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are M3554. The registry lists allocation as na. This study wants to establish the recommended doses and further measure the safety and preliminary antitumor activity of M3554 in participants with soft tissue sarcoma (STS) and glioblastoma, IDH-wildtype.

They plan to enroll about 65 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: M3554

Primary outcome (registry wording): Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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
  • 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 who can join could apply

Public study contact (from the registry)

US Medical Information

888-275-7376

eMediUSA@emdserono.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

11 listed

+ 8 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06641908 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06641908?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06641908?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary