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ABBV-075

Phase 1

Cancer | Small molecule | Oncology |AbbVie Inc.|Last Updated: Nov 29, 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 Enrollment128
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02391480A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With CancerPHASE1 COMPLETED 128Apr 14, 2015Jul 5, 2019Nov 29, 201910 United States
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Study Endpoints
Primary Endpoints
Maximum Tolerated Dose of ABBV-075
Minimum first cycle of dosing (28 days) up to one year for dose escalation segment.

Maximum tolerated dose is defined as the highest dose level at which less than 2 of 6 participants experience the same dose limiting toxicity. If more than 2 participants experience a different dose limiting toxicity, the maximum tolerated dose may be further evaluated or determined to be exceeded based on discussions with the investigators and medical monitors.

Time to Cmax (peak time, Tmax) for ABBV-075
Approximately 24 hours following a single dose of ABBV-075 up to approximately 2 years.
Number of participants with adverse events
Screening, Cycle 1 Day 1, 8 and 15, then Day 1 of each cycle up to approximately 2 years.
Maximum observed plasma concentration (Cmax) of ABBV-075
Approximately 24 hours following a single dose of ABBV-075 up to approximately 2 years.
Area under the curve (AUC)
Cycle 1 Day 1 Pre-dose, 1, 2, 3, 4, 6, 8 and 24 hours post ABBV-075 dosing, and on Cycle 1 Day 15 at 14, 17, 20 hours post dose.

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

Secondary Endpoints
Duration of overall response (DOR)
At screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.
Objective Response Rate (ORR)
At screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.
Progression Free Survival (PFS)
Screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABBV-075EXPERIMENTALDose escalation cohorts of ABBV-075 monotherapy
ABBV-075 and venetoclax combinationEXPERIMENTALExpansion cohorts of ABBV-075 and venetoclax combination therapy
ABBV-075 expansionEXPERIMENTALExpansion cohorts of ABBV-075 monotherapy
Interventions
NameTypeDescription
ABBV-075DRUGABBV-075 Oral tablets
VenetoclaxDRUGVenetoclax tablets, film-coated
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: 1. Participant in the dose escalation cohorts must have histological confirmation of locally advanced or metastatic solid tumor that is either refractory after standard of care therapy for the disease or for which standard of care therapy or does not exist. 2. Participants in th...

Countries:United States
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