Recruiting
Phase 1

M3554

Sponsor:

EMD Serono Research & Development Institute, Inc.

Code:

NCT06641908

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

M3554

Study Details

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

Study ID

NCT06641908

Start date

Nov 8, 2024

Status verified date

Sep, 2026

Completion date

Apr 16, 2027

Anticipated

Primary completion date

Apr 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

52 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation: M3554 Monotherapy

Interventions

M3554

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).

Primary outcome measure

  • Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) [ Time Frame: up to 4 months ]

Central Contacts and Locations

Central contacts

US Medical Information

888-275-7376eMediUSA@emdserono.com

Communication Center

+49 6151 72 5200service@emdgroup.com

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

EMD Serono Research & Development Institute, Inc.

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by EMD Serono Research & Development Institute, Inc. on 2026-09-08.