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OMP-21M18

Phase 1

Solid Tumors | Small molecule | Oncology |Mereo BioPharma Group plc|Last Updated: Sep 10, 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 Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00744562A Phase 1 Dose Escalation Study of OMP-21M18 in Subjects With Solid TumorsPHASE1 COMPLETED 42Aug 1, 2008Jan 1, 2012Sep 10, 20203 United States
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Study Endpoints
Primary Endpoints
To determine the safety of OMP-21M18 in subjects with previously treated solid tumors
continuous
Secondary Endpoints
To determine the pharmacokinetics of OMP-21M18 in subjects with previously treated solid tumors
First 8 doses and following treatment termination
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Open-label OMP-21M18EXPERIMENTAL -
Interventions
NameTypeDescription
OMP-21M18DRUG0.5, 1, 2.5, 5, and 10 mg/kg weekly until day 56. If patient has not progressed may continue with original dose administered every other week until progression
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Eligibility Criteria
Age Range21 Years — N/A
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 2 x 2 cm and is ...

Countries:United States
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