Anti-GD2 ADC M3554 in Advanced Solid Tumors

NCT06641908 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: MS201460_00012024-513687-26-00
• Study Type: interventional
• Target: 52
• Locations: 6 countries
• Sites: 11

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

Conditions

Advanced Solid Tumor

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)

  up to 4 months

Secondary Outcomes (5)

• 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

• 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)

Study Arms (1)

Dose Escalation: M3554 Monotherapy

EXPERIMENTAL

Drug: M3554

Interventions

M3554 DRUG

M3554 will be administered at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose is determined in participants with STS (dose escalation A) and glioblastoma and IDH wildtype (dose escalation B).

Dose Escalation: M3554 Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EMD Serono Research & Development Institute, Inc.: lead
• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (11)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York - Memorial Sloan Kettering Cancer Center (CC)- Westc

New York, New York, 10022, United States

WITHDRAWN

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

Institut Bergonié - Service d'Oncologie Médicale

Bordeaux, France

RECRUITING

Centre Oscar Lambret - cancerologie generale

Lille, France

RECRUITING

Centre Leon Berard - Service d'Oncologie Medicale

Lyon, France

RECRUITING

Centre Antoine Lacassagne - Service d'Hématologie Oncologie

Nice, France

RECRUITING

National Cancer Center Hospital

Chūōku, Japan

RECRUITING

Universitaetsspital Zuerich - Klinik fuer Neurologie

Zurich, 8091, Switzerland

RECRUITING

Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey)

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

Related Links

• Trial Awareness and Transparency website
• US Medical Information website, Medical Resources

MeSH Terms

Conditions

Glioblastoma; Sarcoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Connective and Soft Tissue

Study Officials

• Medical Responsible

  EMD Serono Research & Development Institute, Inc.

  STUDY DIRECTOR

Central Study Contacts

US Medical Information

CONTACT

888-275-7376; eMediUSA@emdserono.com

Communication Center

CONTACT

+49 6151 72 5200; service@emdgroup.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: November 8, 2024
• Primary Completion (Estimated): April 16, 2027
• Study Completion (Estimated): April 16, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); FR (4); US (3); JP (1); CH (1); BE (1)