Anti-GD2 ADC M3554 in Advanced Solid Tumors
- Registration Number
- NCT06641908
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 52
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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 systemic therapy for the metastatic setting including anthracyclines. Previous trabectidin, eribulin, pazopanib or any other drug approved for the different STS subtypes in second line (2L) or beyond will not be required for enrollment but will be allowed (for example [e.g] trabectedin, pazopanib for leiomyosarcoma (LMS); ifosfamide, gemcitabine-based combinations, trabectedin, eribulin, pazopanib for liposarcoma (LPS); trabectedin, gemcitabine, and docetaxel, pazopanib for undifferentiated pleomorphic sarcoma [UPS]). 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.
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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.
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Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1
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Participants with adequate hematologic, hepatic and renal function as defined in protocol
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation: M3554 Monotherapy M3554 -
- Primary Outcome Measures
Name Time Method Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) up to 4 months
- Secondary Outcome Measures
Name Time Method 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) 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 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
Trial Locations
- Locations (9)
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 cedex, France
Centre Oscar Lambret - cancerologie generale
🇫🇷Lille cedex, France
Centre Leon Berard - Service d'Oncologie Medicale
🇫🇷Lyon, France
Centre Antoine Lacassagne - Service d'Hématologie Oncologie
🇫🇷Nice cedex 02, France
National Cancer Center Hospital
🇯🇵Chuo-ku, Japan