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M3554

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Aug 12, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

M3554 · 1 trial · 1 indication

Phase 1 1
NCT06641908Anti-GD2 ADC M3554 in Advanced Solid TumorsAdvanced Solid Tumor
RECRUITING52 Analytics
PHASE1RECRUITING
Anti-GD2 ADC M3554 in Advanced Solid Tumors
Advanced Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)
up to 4 months

Secondary Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation: M3554 MonotherapyEXPERIMENTAL -

Interventions

NameTypeDescription
M3554DRUGM3554 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).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

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. * ...

Countries:United StatesBelgiumFranceJapanSwitzerlandUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumor")

Recent Changes (Last 90 Days)

LOWAug 12, 2026NCT06641908lastUpdatePostDate: changed
LOWAug 12, 2026NCT06641908lastUpdatePostDate: changed
LOWJul 15, 2026NCT06641908lastUpdatePostDate: changed
LOWJul 15, 2026NCT06641908lastUpdatePostDate: changed
LOWJul 5, 2026NCT06641908primaryCompletionDate: changed
LOWJul 5, 2026NCT06641908primaryCompletionDate: changed
LOWJul 5, 2026NCT06641908primaryCompletionDate: changed

Frequently asked questions about M3554

What is M3554 used for in advanced solid tumors?

M3554 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, and the ongoing trial is studying its safety and efficacy in patients with advanced solid tumors.

What does M3554 target?

M3554 is an antibody-drug conjugate (ADC) that targets GD2, a tumor-associated antigen. The drug is designed to deliver a cytotoxic payload to GD2-expressing tumor cells, potentially leading to their destruction.

Who makes M3554?

M3554 is being developed by Merck & Company, Inc., a global biopharmaceutical company. Merck is conducting the Phase 1 clinical trial to evaluate the drug's safety and preliminary efficacy in patients with advanced solid tumors.

What phase is M3554 in?

M3554 is in Phase 1 clinical development. The drug is investigational and has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants to assess its safety, tolerability, and pharmacokinetics.

What clinical trials is M3554 in?

M3554 is being studied in a Phase 1 clinical trial with the identifier NCT06641908, titled "Anti-GD2 ADC M3554 in Advanced Solid Tumors." The trial is recruiting 52 participants across multiple countries, including the United States, Belgium, France, Japan, Switzerland, and the United Kingdom.

Is M3554 the same as an anti-GD2 ADC?

Yes, M3554 is an anti-GD2 antibody-drug conjugate. The clinical trial NCT06641908 specifically describes M3554 as an anti-GD2 ADC, indicating that the drug combines an antibody targeting GD2 with a cytotoxic agent for the treatment of advanced solid tumors.