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PDL192

Phase 1

Cancer | Monoclonal antibody | Oncology |Abbott Laboratories|Last Updated: Jan 6, 2012

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
NCT00738764A Trial of PDL192 in Subjects With Advanced Solid TumorsPHASE1 COMPLETED 30 — — Jul 1, 2008Oct 1, 2011Jan 6, 20122 United States
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Study Endpoints
Primary Endpoints
Maximum tolerated dose
after four weeks of dosing
Secondary Endpoints
The incidence and frequency of dose-limiting toxicities; The frequency, severity, and relationship of adverse events and serious adverse events;Incidence of abnormal findings in physical examinations and clinical laboratory values
during estimated average 4 month treatment period and 90 day follow up
Pharmacokinetic profile of PDL192 including maximum serum drug concentration, area under the concentration-time curve from time zero to infinity, systemic clearance, volume of distribution, and elimination half-life
during estimated average 4 month treatment period and 90 day follow up
Incidence of PDL192-specific antidrug antibodies
during estimated average 4 month treatment period and 90 day follow up
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALPDL192 Dose Level 1
Cohort 2EXPERIMENTALPDL192 Dose Level 2
Cohort 3EXPERIMENTALPDL192 Dose Level 3
Cohort 4EXPERIMENTALPDL192 Dose Level 4
Cohort 5EXPERIMENTALPDL192 Dose Level 5
Cohort 6EXPERIMENTALPDL192 Dose Level 6
Interventions
NameTypeDescription
PDL192BIOLOGICALHumanized anti-TWEAK receptor monoclonal IgG1 antibody
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria: 1. Male or female, 18 years of age or older. 2. Subjects with documented advanced solid tumors. 3. Subjects who have previously failed all standard therapies or subjects ...

Countries:United States
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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