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OMP-18R5

Phase 1

Solid Tumors | Monoclonal antibody | Oncology |Mereo BioPharma Group plc|Last Updated: Sep 9, 2020

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 Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01345201A Dose Escalation Study of OMP-18R5 in Subjects With Solid TumorsPHASE1 COMPLETED 35 — — May 1, 2011May 1, 2014Sep 9, 20203 United States
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Study Endpoints
Primary Endpoints
To determine the safety of OMP-18R5 in subjects with previously treated solid tumors
Subjects will be assessed for dose limiting toxicity from Days 0-28. Adverse events will be reported through 30 days after the last dose.
Secondary Endpoints
To determine the pharmacokinetics of OMP-18R5 in subjects with previously treated solid tumors
The first 8 weekly doses and following treatment termination
To determine the immunogenicity of OMP-18R5 in subjects with previously treated solid tumors
Subjects will be assessed during screening, every 4 weeks, treatment termination, weekly for the first 4 weeks following d/c of study drug, Weeks 8 and 12 following d/c of drug.
To assess the preliminary efficacy of OMP-18R5 in subjects with previously treated solid tumors
Every 56 days until disease progression
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
OMP-18R5BIOLOGICALIV infusion. Subjects with stable disease or a response at Day 56 will be allowed to continue until disease progression.
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Eligibility Criteria
Age Range18 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Subjects must have a histologically confirmed malignancy that is metastatic or unresectable for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. In addition, subjects must have a tumor that is at least 1 cm in a single...

Countries:United States
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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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