What this study is
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
What's being tested
- M3554
Intervention · 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).
Study details
- Official title
- 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
- Sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- Advanced Solid Tumor
- Enrolling
- 65 people
- Starts
- 2024-11-08
- Est. completion
- 2027-04-16
- Design
- Open-label, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You 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 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (11)
9 openDana-Farber Cancer Institute
Boston, Massachusetts, United States
RecruitingThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RecruitingMemorial Sloan-Kettering Cancer Center (MSKCC) - New York - Memorial Sloan Kettering Cancer Center (CC)- Westc
New York, New York, United States
Withdrawn
8 sites outside the US
UZ Leuven
Leuven, Belgium
RecruitingInstitut Bergonié - Service d'Oncologie Médicale
Bordeaux, France
RecruitingCentre Oscar Lambret - cancerologie generale
Lille, France
RecruitingCentre Antoine Lacassagne - Service d'Hématologie Oncologie
Nice, France
RecruitingNational Cancer Center Hospital
Chūōku, Japan
RecruitingUniversitaetsspital Zuerich - Klinik fuer Neurologie
Zurich, Switzerland
RecruitingRoyal Marsden Hospital-Sutton - Dept of Oncology (Surrey)
Sutton, Surrey, United Kingdom
RecruitingCentre Leon Berard - Service d'Oncologie Medicale
Lyon, France
Active, not recruiting
Study team
Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID MS201460_0001
Study director
Medical Responsible
EMD Serono Research & Development Institute, Inc.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.