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OMP-305B83

Phase 1

Advanced Solid Tumor Malignancies | Small molecule | 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 Enrollment71
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02298387A Phase 1 Study of OMP-305B83 in Subjects With Solid TumorsPHASE1 COMPLETED 71 — — Dec 22, 2014Sep 8, 2017Aug 11, 20204 United States
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Study Endpoints
Primary Endpoints
Incidence of dose limiting toxicities (DLTs)
Subjects will be assessed for DLTs from Days 0-21. Adverse events will be reported through 30 days after discontinuation of treatment

Number of subjects with a DLT

Incidence of adverse events
Up to 2 years

Number of subjects with adverse events

Secondary Endpoints
Pharmacokinetics (PK) - AUC, Clearance, volume of distribution, apparent half-life
PK analyses at various time points following the 1st and 3rd doses, pre-dose at Day 84 and every 9 weeks while on study, at treatment term, every 6 weeks for 12 weeks post termination
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
OMP-305B83EXPERIMENTALThe dose levels of OMP-305B83 will be 0.5, 1.0, 2.5, 5 and 10 mg/kg administered IV once every 3 weeks.
Interventions
NameTypeDescription
OMP-305B83DRUGintravenous (in the vein) infusions
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Eligibility Criteria
Age Range21 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

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 or they must be ineligible to receive such therapy and/or have declined al...

Countries:United States
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