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Vantictumab

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02005315A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic CancerPHASE1 COMPLETED 30Sep 1, 2013Nov 1, 2017Sep 9, 20205 United States
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Study Endpoints
Primary Endpoints
Phase 1b: Safety and tolerability of vantictumab 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 (Days 0-28)

The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with weekly nab-paclitaxel

Secondary Endpoints
Pharmacokinetics (PK) of vantictumab when administered in combination with nab-paclitaxel and gemcitabine to patients with previously untreated Stage IV pancreatic cancer
Vantictumab will be administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel and gemcitabine will be administered IV on Days 1, 8, and 15 of each cycle.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Vanctictumab (OMP-18R5)EXPERIMENTALVantictumab will be administered by intravenous (IV) infusion.
Nab-PaclitaxelEXPERIMENTALNab-Paclitaxel will be administered by intravenous (IV) infusion.
GemcitabineEXPERIMENTALGemcitabine will be administered by intravenous (IV) infusion.
Interventions
NameTypeDescription
VantictumabDRUGAdministered intravenous (IV) infusion.
Nab-PaclitaxelDRUGNab-Paclitaxel will be administered by intravenous (IV) infusion.
GemcitabineDRUGGemcitabine will be administered by intravenous (IV) infusion.
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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 tumor tissue, either archival FFPE or obtained at study entry through fresh biopsy * ECOG performance status of 0 or 1 * Adequate hematolog...

Countries:United States
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Competitive Landscape -Pancreatic Cancer 186 trials
CompanyTickerTrialsLead PhaseDrugs
Revolution Medicines, Inc.RVMD9PHASE3RMC-6236, Gemcitabine, nab-paclitaxel, Irinotecan, Liposomal irinotecan
Arcus Biosciences, Inc.RCUS3PHASE3Quemliclustat, Nab-paclitaxel, Gemcitabine, Zimberelimab, Etrumadenant
AstraZeneca PLCAZN9PHASE2AZD0901, 5-Fluorouracil, Leucovorin, l-leucovorin, Irinotecan
AngioDynamics, Inc.ANGO2PHASE3Modified FOLFIRINOX Regimen
Pfizer Inc.PFE9PHASE2tisotumab vedotin, pembrolizumab, carboplatin, cisplatin, ponsegromab
AbbVie, Inc.ABBV4PHASE2TTX-030, nab-paclitaxel and gemcitabine, Nab-Paclitaxel and gemcitabine, Telisotuzumab adizutecan, Fluorouracil, Folinic acid/ Leucovorina
Bristol-Myers Squibb CompanyBMY4PHASE2Navlimetostat, Gemcitabine, Nab-paclitaxel, BMS-986340, BMS-936558-01
Immuneering Corp. Class AIMRX2PHASE3Atebimetinib, GnP, mGnP, IMM-1-104 Monotherapy
RenovoRx, Inc.RNXT1PHASE3Gemcitabine, nab-paclitaxel
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Agenus Inc.AGEN5PHASE2Botensilimab, Gemcitabine, Nab-paclitaxel, AGEN1423, Balstilimab
Eli Lilly and CompanyLLY7PHASE1LY4101174, LY4066434., Cetuximab, Nab paclitaxel, Gemcitabine
Merck & Co., Inc.MRK2PHASE2Belzutifan, Sacituzumab tirumotecan, Fluorouracil, Leucovorin or levoleucovorin, Cisplatin
Veracyte, Inc.VCYT1PHASE3Tislelizumab
ArriVent BioPharma, Inc.AVBP3PHASE2JAB-21822, MRG007, JAB-3312
Exelixis, Inc.EXEL1PHASE2Zanzalintinib, Everolimus
HUTCHMED (China) Limited Sponsored ADRHCM1PHASE2Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine, Nab-paclitaxel Plus Gemcitabine, Surufatinib with Nab-paclitaxel, and Gemcitabine
ImmunityBio IncIBRX2PHASE2N-803, Aldoxorubicin, PD-L1 t-haNK, Nab-paclitaxel, Gemcitabine
Candel Therapeutics, Inc.CADL1PHASE2Aglatimagene besadenovec
Incyte CorporationINCY3PHASE2Ruxolitinib, Capecitabine, Regorafenib, Pemigatinib, Retifanlimab
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