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CVX-045

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |Pfizer, Inc.|Last Updated: Dec 13, 2010

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 Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00879554A Safety And Pharmacokinetic Study With CVX-045 In Patients With Advanced Solid TumorsPHASE1 COMPLETED 40 — — Feb 1, 2007Nov 1, 2010Dec 13, 20103 United States
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Study Endpoints
Primary Endpoints
To determine safety and tolerability of CVX-045 as weekly intravenous (IV) infusions in adult patients with advanced solid tumors
Throughout duration of study
To identify and characterize CVX-045-related adverse events (AEs)
Throughout duration of study
Secondary Endpoints
To evaluate the plasma pharmacokinetics (PK) of CVX-045
Days 1, 4, 8, 15, 29
To determine a recommended Phase 2 dose of CVX-045
End of study
To evaluate the potential for immunogenicity of CVX-045
Days 1, 15, 1st day of every subsequent cycle, EOS, 30 Day FU
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
CVX-045BIOLOGICALWeekly, intravenous dose
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Confirmed advanced solid tumors unresponsive to currently available therapies, or for which there is no standard therapy. * Adequate coagulation, liver and renal function. * Candidate for DCE-MRI evaluation. * ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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