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PCA062

Phase 1

Triple Negative Breast Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Dec 19, 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 Enrollment47
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02375958PCA062 in pCAD-positive Tumors.PHASE1 COMPLETED 47Apr 15, 2015Jul 17, 2018Dec 19, 20207 United States, France +4
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Study Endpoints
Primary Endpoints
Incidence rate of dose limiting toxicities
28 days
Secondary Endpoints
Incidence and severity of serious/adverse events
Duration of study (each treatment cycle = 14 days)
Pharmacokinetic parameter Cmax
84 days
Presence of PCA062 anti-bodies
84 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Triple Negative Breast CancerEXPERIMENTAL -
Head and Neck CancerEXPERIMENTAL -
Esophageal CancerEXPERIMENTAL -
Interventions
NameTypeDescription
PCA062DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion criteria: 1. Male or female ≥ 18 years of age 2. Documented pCAD expressing tumor cells with the exception of HNSCC and ESCC. An archived tumor sample collected within 36 months prior to baseline if available, or a new tumor biopsy sample must be available for molecular pre-screening. 3. ...

Countries:United StatesFranceItalyJapanSingaporeSpain
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