RECRUITING

Anti-GD2 ADC M3554 in Advanced Solid Tumors

Conditions

Advanced Solid Tumor Glioblastoma IDH-wildtype Soft tissue sarcomas GD2 prevalence targeted therapy TOP1 inhibitor exatecan

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2024-11-08

Study Completion:2026-09-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06641908

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

US Medical Information

CONTACT

888-275-7376

eMediUSA@emdserono.com

Communication Center

CONTACT

+49 6151 72 5200

service@emdgroup.com

Principal Investigator

Medical Responsible

STUDY_DIRECTOR

EMD Serono Research & Development Institute, Inc.

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: EMD Serono Research & Development Institute, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-08

Study Completion Date2026-09-20

Study Record Updates

Study Start Date2024-11-08

Study Completion Date2026-09-20

Terms related to this study

Keywords Provided by Researchers

Glioblastoma
IDH-wildtype
Soft tissue sarcomas
GD2 prevalence
targeted therapy
TOP1 inhibitor
exatecan

Additional Relevant MeSH Terms

Advanced Solid Tumor