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ABBV-085

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |AbbVie Inc.|Last Updated: Apr 5, 2019

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 Enrollment85
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02565758ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid TumorsPHASE1 COMPLETED 85Sep 18, 2015Mar 25, 2019Apr 5, 201920 United States, France +1
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Study Endpoints
Primary Endpoints
Terminal elimination half life of ABBV-085.
UP to 24 months
Maximum observed plasma concentration (Cmax) of ABBV-085.
Up to 24 months
Number of participants with Adverse Events
Up to 24 months

Collect all adverse events at each visit.

Area under the curve (AUC) from time zero to the last measurable concentration AUC(0-t) of ABBV-085.
Up 24 months

AUC (0-t) = Area under the serum concentration curve from time zero (pre-dose) to the time of the last measurable concentration.

Secondary Endpoints
Objective response rate (ORR)
Up to 24 months
Progression free survival (PFS)
Up to 24 months
Duration of overall response (DOR)
Up to 24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A4 (ABBV-085)EXPERIMENTALABBV-085 administered on at 28 day cycle and enrolling at MD Anderson
Arm A3 (ABBV-085)EXPERIMENTALABBV-085 will be administered at every cycle (28-day cycles).
Interventions
NameTypeDescription
ABBV-085DRUGAdministered as an intravenous infusion in 28-day dosing cycles.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: 1. Participants with advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. 3. Participants must have measurable disease per Response Evaluation Criteria In...

Countries:United StatesFranceSpain
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