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IMC-3G3

Phase 1

Solid Tumors | Monoclonal antibody | Oncology |Eli Lilly and Company|Last Updated: Jun 28, 2011

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00768391Study of IMC-3G3 in Patients With Tumors That Are Not Responding to Standard Therapies or No Therapy is AvailablePHASE1 COMPLETED 20Dec 1, 2006Jan 1, 2010Jun 28, 20112 United States
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Study Endpoints
Primary Endpoints
Summary of Participants Reporting Adverse Events
Approximately 36 months
Maximum Tolerated Dose (MTD)
Approximately 36 months

After all patients complete a cohort, toxicity data is reviewed before the next cohort of patients is treated at the next higher dose level

Secondary Endpoints
Pharmacokinetics
6 weeks
Anti-IMC-3G3 Antibody Assessment
Approximately 36 months
Antitumor Activity of IMC-3G3 as Monotherapy
6 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
IMC-3G3EXPERIMENTALAll patients will receive intravenous infusions of IMC-3G3, with the dose depending on which cohort they are enrolled into.
Interventions
NameTypeDescription
IMC-3G3BIOLOGICALIntravenously, once every week for Cohorts 1 through 3 and once every other week for Cohorts 4 and 5. Starting dose will be 4mg/kg in Cohort 1, with dose doubling between cohorts. Dose escalation of 100% (2 x previous dose) Dose escalation increment reduced to 33% (1.33 x previous dose). Cohorts 4 and 5 will receive 15mg/kg and 20mg/kg, intravenously, once every other week.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Histopathological-documented, measurable, or non measurable, advanced primary tumor or recurrent solid tumor or lymphoma unresponsive to standard therapy or for which there is no standard therapy available. 2. Eastern Cooperative Oncology Group (ECOG) performance status score...

Countries:United States
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