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PDL192

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

PDL192 · 1 trial · 1 indication

Phase 1 1
NCT00738764A Trial of PDL192 in Subjects With Advanced Solid TumorsCancer
COMPLETED30 Analytics
PHASE1COMPLETED
A Trial of PDL192 in Subjects With Advanced Solid Tumors
CancerUnlock trial analytics

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 to 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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Frequently asked questions about PDL192

What is PDL192 used for?

PDL192 is an investigational monoclonal antibody being developed for the treatment of cancer. It is intended for patients with advanced solid tumors, as evaluated in a Phase 1 clinical trial. The drug is not yet approved and remains in clinical development.

Who is developing PDL192?

PDL192 is being developed by Abbott Laboratories, a company traded under the ticker ABT. The drug is an investigational monoclonal antibody in Phase 1 clinical development for oncology indications.

What phase is PDL192 in?

PDL192 is in Phase 1 clinical development. It has completed a Phase 1 trial in patients with advanced solid tumors. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is PDL192 in?

PDL192 has been studied in a Phase 1 clinical trial with the identifier NCT00738764, titled "A Trial of PDL192 in Subjects With Advanced Solid Tumors." This trial enrolled 30 participants in the United States and has been completed.

Is PDL192 the same as other drugs?

PDL192 is a distinct investigational monoclonal antibody developed by Abbott Laboratories. No alternative names for this drug have been reported in clinical trial records.