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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513687-26-00 | Other Identifier | CTIS | |
| jRCT2031240430 | Other Identifier | JRCT (Japan) |
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| Name | Class |
|---|---|
| Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation: M3554 Monotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M3554 | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) | up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Plasma Concentrations of M3554 | Cycle 1 Day 1 to Cycle 3 Day 15 and every second cycle from Cycle 4 (each cycle is of 21 days), assessed up to approximately 4 months | |
| Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 as Assessed by Investigator |
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Inclusion 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 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
Other protocol defined inclusion criteria 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 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
Other protocol defined exclusion criteria could apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US Medical Information | Contact | 888-275-7376 | eMediUSA@emdserono.com | |
| Communication Center | Contact | +49 6151 72 5200 | service@emdgroup.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | EMD Serono Research & Development Institute, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States | |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| US Medical Information website, Medical Resources | View source |
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We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://bit.ly/IPD21
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| Time from randomization to planned assessment at 4 months |
| Duration of Response (DoR) According to RECIST Version 1.1 or RANO 2.0 as Assessed by Investigator | Time from randomization to planned assessment at 4 months |
| Progression-free Survival (PFS) According to RECIST Version 1.1 or RANO 2.0 as Assessed by Investigator | Time from randomization to planned assessment at 4 months |
| Change from Baseline in Corrected QT Interval (QTc) Interval | Pre-dose on Day 1 (baseline) up to 24 hours post-dose Day 1, Day 2, Day 5, Day 8 of Cycle 1 and Cycle 3 Day 1 (each Cycle is 21 days) |
| Memorial Sloan-Kettering Cancer Center (MSKCC) - New York - Memorial Sloan Kettering Cancer Center (CC)- Westc |
| Withdrawn |
| New York |
| New York |
| 10022 |
| United States |
| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| UZ Leuven | Recruiting | Leuven | Belgium |
| Institut Bergonié - Service d'Oncologie Médicale | Recruiting | Bordeaux | France |
| Centre Oscar Lambret - cancerologie generale | Recruiting | Lille | France |
| Centre Leon Berard - Service d'Oncologie Medicale | Recruiting | Lyon | France |
| Centre Antoine Lacassagne - Service d'Hématologie Oncologie | Recruiting | Nice | France |
| National Cancer Center Hospital | Recruiting | Chūōku | Japan |
| Universitaetsspital Zuerich - Klinik fuer Neurologie | Recruiting | Zurich | 8091 | Switzerland |
| Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey) | Recruiting | Sutton | Surrey | SM2 5PT | United Kingdom |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |