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OMP-54F28 with Sorafenib

Phase 1

Hepatocellular Cancer | 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 Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02069145Dose Escalation Study of OMP-54F28 in Combination With Sorafenib in Patients With Hepatocellular CancerPHASE1 COMPLETED 10 — — Jan 1, 2014Jul 1, 2017Aug 11, 20206 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability of OMP-54F28 in combination with sorafenib in patients with hepatocellular cancer
Subjects will be treated and observed for DLT through the end of the first cycle (from Day 0 - 21)

The maximum tolerated dose (MTD) will be determined in patients treated with OMP-54F28 in combination with sorafenib in patients with hepatocellular cancer

Secondary Endpoints
Pharmacokinetics (PK) of OMP-54F28 and sorafenib when administered in combination to patients with hepatocellular cancer
OMP-54F28 will be administered IV on Day 1 of each 21 day cycle. Plasma sample for Parmacokinetics (PK) analysis to be obtained at various time points, 30 minutes after end of OMP-54F28 infusion and before sorafenib treatment
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Drug: OMP-54F28, with SorafenibEXPERIMENTAL -
Interventions
NameTypeDescription
OMP-54F28 with SorafenibDRUG -
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Eligibility Criteria
Age Range18 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Signed Informed Consent Form * Age ≥18 years * Histologically documented hepatocellular carcinoma * Locally advanced or metastatic disease * Availability of FFPE tumor tissue, either archival or obtained at study entry through fresh biopsy o Tumor tissue from fine needle as...

Countries:United States
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