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IMC-RON8

Phase 1

Cancer | Monoclonal antibody | Oncology |Eli Lilly and Company|Last Updated: Feb 15, 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 Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01119456A Study of IMC-RON8 in Advanced Solid TumorsPHASE1 COMPLETED 39May 1, 2010Nov 1, 2013Feb 15, 20193 United States
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Study Endpoints
Primary Endpoints
Maximum Tolerated Dose (MTD) of IMC-RON8
Baseline through end of study treatment (up to 48 weeks)

The MTD was the previous dose level to that in which 2 of 6 participants experienced dose-limiting toxicities (DLTs). DLTs were defined as any of the following events: Grade 4 neutropenia lasting \>7 days; any Grade 3 or 4 neutropenia complicated by fever ≥38.5 degrees Celsius or infection, Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage; Grade 3 hepatic toxicity; or any Grade 3 or 4 nonhematologic toxicity (excluding alopecia, fatigue, anorexia, nausea, and vomiting that is controlled with antiemetics).

Secondary Endpoints
Pharmacokinetics (PK): Maximum Concentration (Cmax) of IMC-RON8
First and fourth or fifth infusion: Predose, immediately postdose through 168 or 336 hours postdose
PK: Area Under the Curve (AUC) of IMC-RON8
First and fourth or fifth infusion: Predose, immediately postdose through 168 or 336 hours postdose
Immunogenicity of IMC-RON8
Prior to first infusion through study completion (up to 52 weeks)
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Study Design & Arms
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IMC-RON8EXPERIMENTALA monoclonal antibody to human macrophage-stimulating 1-receptor-8 (RON8).
Interventions
NameTypeDescription
IMC-RON8BIOLOGICAL5 milligrams per kilogram (mg/kg) intravenously (IV) Once a week for each 4-week treatment cycle, for a total of four doses per cycle. The initial 4-week treatment cycle will be followed by a 2-week observation period. Cohort 1
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * The participant has histologically-confirmed advanced primary or recurrent solid tumors that have not responded to standard therapy or for which no standard therapy is available * The participant has measurable or non-measurable disease * The participant has not received major...

Countries:United States
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