Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
52 participants
INTERVENTIONAL
2024-11-08
2027-04-16
Brief Summary
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Study details include:
Study Duration per participant: Approximately 4 months
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation: M3554 Monotherapy
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* STS only: Participants with history of brain metastasis, leptomeningeal metastasis, or participants with spinal cord compression
18 Years
ALL
No
Sponsors
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono Research & Development Institute, Inc.
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York - Memorial Sloan Kettering Cancer Center (CC)- Westc
New York, New York, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
UZ Leuven
Leuven, , Belgium
Institut Bergonié - Service d'Oncologie Médicale
Bordeaux, , France
Centre Oscar Lambret - cancerologie generale
Lille, , France
Centre Leon Berard - Service d'Oncologie Medicale
Lyon, , France
Centre Antoine Lacassagne - Service d'Hématologie Oncologie
Nice, , France
National Cancer Center Hospital
Chūōku, , Japan
Universitaetsspital Zuerich - Klinik fuer Neurologie
Zurich, , Switzerland
Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey)
Sutton, Surrey, United Kingdom
Countries
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Central Contacts
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Related Links
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Trial Awareness and Transparency website
US Medical Information website, Medical Resources
Other Identifiers
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2024-513687-26-00
Identifier Type: OTHER
Identifier Source: secondary_id
MS201460_0001
Identifier Type: -
Identifier Source: org_study_id
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