Anti-GD2 ADC M3554 in Advanced Solid Tumors

Description

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

Conditions

Advanced Solid Tumor

Study Overview

Study Details

Study overview

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

A Phase 1, Two-Part, Multicenter, Open-Label First in Human Study of Anti-GD2 Antibody Drug Conjugate M3554 in Participants With Advanced Solid Tumors

Anti-GD2 ADC M3554 in Advanced Solid Tumors

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

New York

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York - Memorial Sloan Kettering Cancer Center (CC)- Westc, New York, New York, United States, 10022

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

EMD Serono Research & Development Institute, Inc.,

Medical Responsible, STUDY_DIRECTOR, EMD Serono Research & Development Institute, Inc.

Study Record Dates

2026-09-20