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OMP-54F28

Phase 1

Solid Tumors | Monoclonal antibody | Oncology |Mereo BioPharma Group plc|Last Updated: Aug 11, 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 Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01608867A Dose Escalation Study of OMP-54F28 in Subjects With Solid TumorsPHASE1 COMPLETED 26 — — Jun 1, 2012Jun 1, 2017Aug 11, 20203 United States
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Study Endpoints
Primary Endpoints
• To determine the safety of OMP-54F28 in subjects with previously treated solid tumors
Subjects will be assessed for dose limiting toxicities from Days 0-28. Adverse events will be reported through 30 days after the last dose.
Secondary Endpoints
To determine the pharmacokinetics of OMP-54F28 in subjects with previously treated solid tumors
Baseline,end of infusion,0.5,1,3,6,24, and 72 hours post-infusion (1st infusion) 0.5, 1, 3, 6, 24, 72, and 168 hours (3rd infusion),before/end 2nd infusion,Days 7, 14, 28, and 35. After termination: Weekly for the first 4 weeks, then at Week 8 and 12
To determine the immunogenicity of OMP-54F28 in subjects with previously treated solid tumors
Subjects will be assessed during screening ,every 4 weeks while on study drug, at the time of treatment termination, then weekly for the first 4 weeks, then at Week 8 and 12 following discontinuation of study drug
To assess the preliminary efficacy of OMP-54F28 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-54F28BIOLOGICALdose escalation of 0.5, 1, 2.5, 5, and 10 mg/kg administered IV once every 3 weeks
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Eligibility Criteria
Age Range18 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for the study: 1. Subjects must have a histologically confirmed malignancy that is metastatic or unresectable and must have received the standard therapies for their malignancy. In addition, subjects must have a tu...

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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