NCT06641908PHASE1Recruiting
Anti-GD2 ADC M3554 in Advanced Solid Tumors
EMD Serono Research & Development Institute, Inc.
Start Date
11/8/2024
Completion Date
4/16/2027
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
Eligibility Criteria
Age Range: 18 years to No maximum
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
* Exclusion Criteria:
* 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
Interventions
DRUG
M3554
Conditions
Advanced Solid Tumor
Locations
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York - Memorial Sloan Kettering Cancer Center (CC)- Westc
New York, New York 10022
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
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, 8091
Switzerland
Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey)
Sutton, Surrey SM2 5PT
United Kingdom