Advanced Solid Tumor study: M3554
Official title Anti-GD2 ADC M3554 in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06641908
What this study is testing
What is M3554?
M3554 is an investigational drug being studied as a potential treatment for advanced solid tumors, including soft tissue sarcoma and glioblastoma (IDH‑wildtype).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find the best dose of M3554 and to see how safe it is and whether it shows early signs of shrinking tumors.
- Who it's for
- Adults who have soft‑tissue sarcoma or IDH‑wildtype glioblastoma that cannot be cured with standard treatments.
- What's involved
- Participants will receive M3554 by infusion and undergo regular safety labs, imaging scans, and check‑ups to monitor side effects and tumor response.
- Time commitment
- The trial lasts about four months, with multiple clinic visits for treatment and assessments during that time.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Escalation A: participants with documented histopathological diagnosis of locally advanced or metastatic STS with unresectable disease that has...
- Participants with resectable locally advanced or metastatic disease, who had surgery before study entry will be allowed in the trial if there is...
- Escalation B: participants with documented histopathological diagnosis of glioblastoma, IDH-wildtype, who have progressed after ONLY one prior line...
- 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
You likely can't join if
- Participant has a history of malignancy other than STS or glioblastoma (depending on the escalation/expansion cohort) within 3 years before the date...
- STS only: Participants with history of brain metastasis, leptomeningeal metastasis, or participants with spinal cord compression
- Other protocol defined exclusion criteria could apply.
See the full eligibility 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...
- 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...
- 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...
- 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 could apply
- 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...
- STS only: Participants with history of brain metastasis, leptomeningeal metastasis, or participants with spinal cord compression
- Other protocol defined exclusion criteria could apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
- Houston, Texas, United States
- Leuven, Belgium
- Bordeaux, France
- Lille, France
- Nice, France
- Chūōku, Japan
- Zurich, Switzerland
- Sutton, Surrey, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States; Houston, Texas, United States; Leuven, Belgium; Bordeaux, France; Lille, France; Nice, France and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.