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ABT-700

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |AbbVie Inc.|Last Updated: Nov 21, 2017

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 Enrollment74
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01472016Study of ABT-700 in Subjects With Advanced Solid TumorsPHASE1 COMPLETED 74 — — Oct 6, 2011Apr 27, 2017Nov 21, 2017 - —
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Study Endpoints
Primary Endpoints
To evaluate the safety and tolerability of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib
First cycle of treatment through 60 day follow-up visit

Evaluation of vital signs, clinical lab testing, physical exams and adverse event monitoring

To Evaluate the pharmacokinetics of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib
At each cycle of treatment through 60 days after last dose.

Pharmacokinetic profile of ABT-700 analyzed from blood samples

To determine the recommended Phase 2 dose for ABT-700
First cycle of treatment through 60 day follow-up visit
Secondary Endpoints
To evaluate the preliminary efficacy of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib
Screening through 60 day follow-up visit
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort AEXPERIMENTALABT-700 will be administered by intravenous infusion at escalating dose levels in 21-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate ABT-700.
Cohort BEXPERIMENTALABT-700 plus docetaxel.
Cohort CEXPERIMENTALABT-700 plus FOLFIRI/cetuximab
Cohort DEXPERIMENTALABT-700 plus erlotinib
Interventions
NameTypeDescription
ABT-700DRUGABT-700 will be administered by intravenous infusion at escalating dose levels on day 1 in 21-day dosing cycles. Additional subjects will be enrolled in an dose expansion cohort that will further evaluate ABT-700.
docetaxelDRUGDocetaxel will be administered by intravenous infusion on Day 1 in 21-day dosing cycles.
FOLFIRIDRUG5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion on Day 1 and 15 in 28-day dosing cycles.
cetuximabDRUGCetuximab will be administered by intravenous infusion weekly.
erlotinibDRUGErlotinib will be taken orally daily.
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subject with advanced solid tumors; Dose-expansion: evidence for MET gene amplification. * Subject must have disease: a) that is not amenable to surgical resection, or b) that has progressed or recurred despite standard therapy, or c) that has failed to respond to standard the...

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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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