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OMP-52M51

Phase 1

Relapsed or Refractory Lymphoid Malignancies | Small molecule | Other |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 Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01703572A Dose Escalation Study of OMP-52M51 in Subjects With Lymphoid MalignanciesPHASE1 COMPLETED 24 — — Oct 1, 2012Jan 1, 2016Sep 9, 202010 United States
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Study Endpoints
Primary Endpoints
Safety profile of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies
Subjects will be assessed for DLTs from Days 0-29. Adverse events will be reported through 30 days after the last dose
Secondary Endpoints
Pharmacokinetics (PK) of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies
PK analyses at various time points following the 1st and 2nd doses, immediately pre and post-dose for all subsequent doses at treatment term, every 4 weeks after discontinuation of study drug or 12 weeks
Immunogenicity of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies
At baseline, every 4 weeks, at treatment termination and every 4 weeks after the discontinuation of the study drug for 12 weeks.
Preliminary efficacy of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies
Evaluation for response will be assessed every 56 days and will be based on disease specific criteria.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
OMP-52M51EXPERIMENTAL -
Interventions
NameTypeDescription
OMP-52M51DRUG -
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Eligibility Criteria
Age Range18 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: 1. Lymphoid malignancy that has relapsed or is refractory after two or more treatments that are FDA approved or are commonly used clinically. 2. Subjects must have progressive disease requiring therapy. Subjects who are candidates for observation only are not eligible. 3. Subjec...

Countries:United States
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