Trials / Recruiting
RecruitingNCT06641908
Anti-GD2 ADC M3554 in Advanced Solid Tumors
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- Sponsor
- EMD Serono Research & Development Institute, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | M3554 | 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). |
Timeline
- Start date
- 2024-11-08
- Primary completion
- 2027-04-16
- Completion
- 2027-04-16
- First posted
- 2024-10-15
- Last updated
- 2026-04-15
Locations
11 sites across 6 countries: United States, Belgium, France, Japan, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06641908. Inclusion in this directory is not an endorsement.