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mRNA-4106

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |Moderna, Inc.|Last Updated: May 27, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06880549A Study of mRNA-4106 or mRNA-4200 Administered Alone or in Combination With Anti-Cancer Agents in Participants With Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 42Mar 25, 2025Aug 3, 2027May 27, 20263 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Dose Limiting Toxicities (DLTs)
For Arm 1: Days 1-21 and Arm 2: Days 1-42
Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
Up to 2 years and 3 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1 (Dose Escalation): mRNA-4106 AloneEXPERIMENTALParticipants will receive mRNA-4106 at a test dose as monotherapy.
Arm 2 (Dose Escalation): mRNA-4200 Alone and in Combination with PembrolizumabEXPERIMENTALParticipants will receive mRNA-4200 as monotherapy, followed by mRNA-4200 in combination with pembrolizumab, and continuation of pembrolizumab alone.
Interventions
NameTypeDescription
mRNA-4106BIOLOGICALIntramuscular injection
PembrolizumabBIOLOGICALIntravenous infusion
mRNA-4200BIOLOGICALIntramuscular injection
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Key Inclusion Criteria: * Arm 1: Histologically confirmed advanced or metastatic cancer (melanoma, non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), esophageal carcinoma, head and neck squamous cell carcinoma (HNSCC), urinary bladder cancer (UBC), colon/rectal adenocarcinomas, gas...

Countries:United States
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Recent Changes (Last 90 Days)
HIGHMay 28, 2026NCT06880549Enrollment: 57 → 42
HIGHMay 28, 2026NCT06880549Enrollment: 57 → 42
LOWMay 26, 2026NCT06880549primaryCompletionDate: changed
LOWMay 24, 2026NCT06880549studyFirstPostDate: changed