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M3554

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Apr 15, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06641908Anti-GD2 ADC M3554 in Advanced Solid TumorsPHASE1 RECRUITING 52 — — Nov 8, 2024Apr 16, 2027Apr 15, 202611 United States, Belgium +4
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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 — 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
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06641908studyFirstPostDate: changed