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OMP-54F28, Nab-Paclitaxel and Gemcitabine

Phase 1

Pancreatic Cancer | Small molecule | Oncology |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 Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02050178Dose Escalation Study of OMP-54F28 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic CancerPHASE1 COMPLETED 26 — — Nov 1, 2013Jun 15, 2017Sep 9, 20205 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability of OMP-54F28 in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer
Subjects will be treated and observed for DLT through the end of the first cycle (from Day 0 - 28)

The maximum tolerated dose (MTD) will be determined in patients treated with gemcitabine in combination with weekly nab-paclitaxel (from Day 0 - 28)

Secondary Endpoints
Pharmacokinetics (PK) of OMP-54F28 when administered in combination with nabpaclitaxel and gemcitabine to patients with previously untreated Stage IV pancreatic cancer
Plasma sample for Pharmacokinetics (PK) analysis to be obtained prior to the gemcitabine infusion and before nabpaclitaxel infusion from Day 0 to treatment termination
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Drug: OMP-54F28, Nab-Paclitaxel and GemcitabineEXPERIMENTAL -
Interventions
NameTypeDescription
OMP-54F28, Nab-Paclitaxel and GemcitabineDRUG -
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Eligibility Criteria
Age Range18 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Signed Informed Consent Form * Age ≥18 years * Histologically documented Stage IV ductal adenocarcinoma of the pancreas * Availability of FFPE tumor tissue, either archival or obtained at study entry through fresh biopsy * Tumor tissue from fine needle aspiration is not accept...

Countries:United States
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Competitive Landscape -Pancreatic Cancer 186 trials
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