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M3554

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Merck KGaA|Last Updated: Sep 8, 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 Tumor
NCT0664190852
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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")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)

LOWSep 8, 2026NCT06641908lastUpdatePostDate: changed
LOWSep 8, 2026NCT06641908lastUpdatePostDate: changed
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