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IMC-3C5

Phase 1

Neoplasms | Monoclonal antibody | Oncology |Eli Lilly and Company|Last Updated: Jun 17, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01288989A Study of Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid TumorsPHASE1 COMPLETED 44Mar 1, 2011Jul 1, 2014Jun 17, 20194 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Adverse Events (AEs)
Baseline up to 46 months

AEs include serious AEs (SAEs). AEs do not distinguish whether the events are treatment-emergent. A summary of serious and other non-serious AEs, regardless of causality, is presented in the Reported Adverse Event module.

Number of Participants Reporting Dose-Limiting Toxicity (DLT)
Baseline up to 16 Months

A DLT was defined as any adverse event (National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\], Version 4.0) considered by the investigator to be definitely, probably, or possibly related to IMC-3C5, that occurred during the DLT Assessment Period (weeks 1 through 6) as follows: * Any Grade 3 or 4 hematologic toxicity * Any Grade 3 or 4 nonhematologic toxicity (excluding fatigue or anorexia lasting \<7 days, or Grade 3 nausea and/or vomiting that persisted for \<2 days following appropriate supportive care intervention)

Secondary Endpoints
Antitumor Activity of Single Agent IMC-3C5: Best Overall Response (BOR)
Baseline up to 46 Months
Maximum Concentration (Cmax) of IMC-3C5 - First Infusion
Prior to 1st infusion (Day 1 of Cycle 1), immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168 hours post infusion for cohorts 1-4. Prior to 1st infusion and 1 hour post infusion for cohort 5. (Cycle 1 = 4 - 6 weeks.)
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Drug Concentration (AUC 0-tlast) of IMC-3C5 - First Infusion
Prior to 1st infusion (Day 1 of Cycle 1), immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168 hours post infusion for cohorts 1-4. (Cycle 1 = 6 weeks.)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IMC-3C5EXPERIMENTALParticipants receiving IMC-3C5 intravenously
Interventions
NameTypeDescription
IMC-3C5BIOLOGICALEscalating doses of IMC-3C5 administered intravenously (i.v.), weekly or every other week
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Participant has histologic or cytologic confirmation of cancer 2. Participant has an advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available 3. Participant has measurable or nonmeasurable disease according to Response Evaluati...

Countries:United States
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