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Panitumumab

Phase 1

Colorectal Cancer | Monoclonal antibody | Oncology |Exelixis, Inc.|Last Updated: Feb 12, 2021

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment29
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02008383Cabozantinib and Panitumumab to Treat KRAS Wild-Type Metastatic Colorectal CancerPHASE1 COMPLETED 29Jan 1, 2014Aug 29, 2018Feb 12, 20211 United States
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Study Endpoints
Primary Endpoints
Recommended phase II dose (RPTD) for the combination of cabozantinib and panitumumab
RPTD for the study will be determined at the completion of Phase I dose escalation cohort; estimated as 1 year
Objective response rate (ORR) of cabozantinib monotherapy in patients with prospectively identified MET amplified metastatic colorectal cancer
Approximately every 8 weeks and/or restaging
Secondary Endpoints
Non-dose limiting toxicities of cabozantinib and panitumumab.
Continuous, every 4 weeks minimum until end of study estimated at 4 years
Response rate of cabozantinib and panitumumab
approximately every 8 weeks and/or restaging
Progression free survival associated with the cabozantinib and panitumumab regimen
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cabozantinib and PanitumumabEXPERIMENTAL60 mg Cabozantinib PO daily and 6 mg/kg Panitumumab IV every 2 weeks.
CabozantinibEXPERIMENTAL60 mg Cabozantinib PO daily.
Interventions
NameTypeDescription
PanitumumabBIOLOGICALThe FDA approved dose for panitumumab is 6mg/kg IV, every two weeks. This is the dose and schedule that will be used in this study.
CabozantinibDRUGThere will be three parts to this phase I study: 1) the Combination Dose Finding cohort; 2) the Combination Expansion cohort; and 3) the Monotherapy MET Amplified cohort. Cabozantinib will start at a dose of 60 mg daily with reductions to 40 and 20 mg daily possible in the dose finding cohort. The combination expansion cohort dose will determined by the dose finding cohort. The Monotherapy MET Amplified cohort will recieve 60 mg Cabozantinib daily.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

MET Amplification Screening Test Inclusion Criteria: 1. Histologically and/or cytologically confirmed and radiographically measurable KRAS wild-type adenocarcinoma of the colon or rectum that is metastatic and/ or unresectable. Subjects must have been treated with a fluoropyrimidine (e.g., 5-fluoro...

Countries:United States
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Competitive Landscape -Colorectal Cancer 263 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV8PHASE3Telisotuzumab Adizutecan, Telisotuzumab adizutecan, Bevacizumab, Trifluridine/Tipiracil, ABBV-400
Bristol-Myers Squibb CompanyBMY7PHASE3Ipilimumab, Oxaliplatin, Leucovorin, Fluorouracil, Irinotecan
Merck & Co., Inc.MRK6PHASE3Pembrolizumab, Oxaliplatin, Leucovorin, 5-fluorouracil, Irinotecan
Johnson & JohnsonJNJ5PHASE3Amivantamab, Cetuximab, 5-fluorouracil, Leucovorin calcium/Levoleucovorin, Oxaliplatin
Pfizer Inc.PFE12PHASE3PF-08634404, Bevacizumab, Chemotherapy, tucatinib, trastuzumab
GSK plc Sponsored ADRGSK6PHASE3Dostarlimab, CAPEOX, FOLFOX, GSK4418959, PD-1 inhibitor
Exelixis, Inc.EXEL5PHASE3XL092, Atezolizumab, Regorafenib, cabozantinib, atezolizumab
Summit Therapeutics IncSMMT3PHASE3Drug: Ivonescimab, Drug: Bevacizumab, AK112, AK117, Oxaliplatin
Natera, Inc.NTRA4PHASE3Capecitabine, Oxaliplatin, Folfirinox, FOLFOX regimen
Agenus Inc.AGEN4PHASE3Balstilimab, Botensilimab, CR6086, AGEN2034
Incyte CorporationINCY2PHASE3INCA33890, Bevacizumab, FOLFOX, Ruxolitinib, Capecitabine
Amgen Inc.AMGN1PHASE3FOLFIRI Regimen, Sotorasib, Panitumumab, Bevacizumab-awwb
Eli Lilly and CompanyLLY8PHASE2LY2157299, Capecitabine, Fluorouracil, LY4066434., Cetuximab
AstraZeneca PLCAZN8PHASE2Datopotamab deruxtecan, Capecitabine, 5-Fluorouracil, Volrustomig, Carboplatin
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE2fruquintinib, FOLFIRI, oxaliplatin , levofolinate calcium , 5-FU, panitumumab, mFOLFOX6 + panitumumab combination therapy
Novartis AG Sponsored ADRNVS7PHASE2Dabrafenib, Trametinib, JDQ443, TNO155, tislelizumab
BioNTech SE Sponsored ADRBNTX3PHASE2RO7198457, PM8002, Chemotherapy Regimen 1, BNT314, BNT327
Regeneron Pharmaceuticals, Inc.REGN2PHASE2Cemiplimab + Fianlimab, VV1, Cemiplimab
Revolution Medicines, Inc.RVMD7PHASE1RMC-6291, Elironrasib, Daraxonrasib, RMC-9805, RMC-6236
Veracyte, Inc.VCYT1PHASE3Tislelizumab
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