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mRNA-2752

Phase 1

Dose Escalation: Relapsed/Refractory Solid Tumor Malignancies or Lymphoma | Monoclonal antibody | Oncology |Moderna, Inc.|Last Updated: Aug 15, 2025

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 Enrollment134
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03739931Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced MalignanciesPHASE1 COMPLETED 134 — — Nov 27, 2018Aug 1, 2025Aug 15, 202524 United States, Australia +1
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Study Endpoints
Primary Endpoints
Number of Participants with Dose Limiting Toxicities (DLTs)
Up to Day 28
Number of Participants with Adverse Events (AEs)
Up to 27 months
Arm B: Overall Response Rate (ORR): Percentage of Participants with Tumor Response (Partial or Complete) Based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) in Cutaneous Melanoma
Up to 2 years
Secondary Endpoints
ORR: Percentage of Participants with Tumor Response (Partial or Complete) Based on RECIST v1.1 and modified RECIST (iRECIST), and Cheson and Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) for Participants With Lymphoma
Up to 2 years
Pharmacokinetics: Maximum Observed Concentration (Cmax)
Predose, immediately after injection, and 15 minutes up to 168 hours postdose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A: mRNA-2752EXPERIMENTALParticipants will be administered mRNA-2752 at an applicable dose as monotherapy.
Arm B: mRNA-2752 + DurvalumabEXPERIMENTALParticipants will be administered mRNA-2752 at an applicable dose in combination with durvalumab.
Arm C: mRNA-2752 Alone or mRNA-2752 + DurvalumabEXPERIMENTALParticipants will be administered mRNA-2752 at an applicable dose as monotherapy or in combination with durvalumab.
Interventions
NameTypeDescription
mRNA-2752BIOLOGICALSolution for intratumoral injection
DurvalumabBIOLOGICALSolution for infusion after dilution
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Written informed consent prior to completing any study-specific procedure * Histologically confirmed advanced or metastatic disease with at least 1 measurable lesion as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Cheson 2016 criteria * Do...

Countries:United StatesAustraliaIsrael
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