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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

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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