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IMC-A12 - /kg

Phase 2

Hepatocellular Carcinoma | Monoclonal antibody | Oncology |Eli Lilly and Company|Last Updated: Jun 4, 2018

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
ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment47
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00906373A Study of IMC-A12 in Combination With Sorafenib in Participants With Advanced Cancer of the LiverPHASE2 COMPLETED 47May 1, 2009May 1, 2014Jun 4, 20187 United States
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Study Endpoints
Primary Endpoints
Progression Free Survival (PFS)
Date of first dose of study drug up PD or death up to 12 months

PFS is defined as the time from date of first dose of study drug until the date of objective PD or death due to any cause, whichever occurs first. PD defined as a ≥20% increase in the sum of the longest diameter (LD) of target lesions using as reference the smallest sum LD since baseline or ≥1 new lesions. Participants who died without PD were considered to have progressed on the date of death. Participants who were alive and without PD were censored at the time of the last objective tumor assessment. Participants who did not progress and are subsequently lost to follow-up were censored at the date of their last objective tumor assessment before loss to follow-up. Participants who progressed or died after ≥2 missed tumor assessment visits were censored at the date of their last objective tumor assessment before missed assessments. Participants who begin a new anticancer therapy were censored at the date of their last objective tumor assessment before initiation of new therapy.

Secondary Endpoints
Number of Participants With Adverse Events (AEs)
First day of treatment up to 22 months
Pharmacokinetic (PK): Maximum Concentration (Cmax) Cycle 1
Cycle 1, Day 1: Predose, 1 hour (h), 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)
PK: Minimum Concentration (Cmin) Cycle 1
Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1, IMC A12 - 10 mg/kgACTIVE_COMPARATORTreatment cycles will repeat until there is evidence of progressive disease (PD), toxicity, or withdrawal. If any participant experiences a dose-limiting toxicity (DLT), an additional 3 participants will be enrolled at this dose level (for a total of 6). If no further DLTs, enrollment into Cohort 2 will occur.
Cohort 2, IMC A12 20 - mg/kgACTIVE_COMPARATORTreatment cycles will repeat until there is evidence of PD, toxicity, or withdrawal.
Interventions
NameTypeDescription
IMC-A12 (cixutumumab) - 10 milligrams/kilogram (mg/kg)BIOLOGICALintravenous infusions 10 mg/kg on Day 1 of each 3-week cycle
IMC-A12 (cixutumumab) - 20 mg/kgBIOLOGICALintravenous infusions 20 mg/kg on Day 1 of each 3-week cycle
SorafenibDRUG400 milligrams (mg) twice per day orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * The participant has histologically or cytologically confirmed, unresectable HCC * The participant has at least one target lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesion(s) must not lay within a previously irradiat...

Countries:United States
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