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IMMU-130

Phase 1

Metastatic Colorectal Cancer | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Aug 19, 2021

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 Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01270698Study of IMMU-130 in Patients With Relapsed/Refractory Colorectal CancerPHASE1 COMPLETED 26May 1, 2011Dec 1, 2014Aug 19, 20211 United States
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Study Endpoints
Primary Endpoints
Safety
Safety will be measured routinely during the 6 months of administration and afterwards during follow-up for up to 5 years

The primary outcome measured will be safety of IMMU-130 administered at different dose levels. Safety will be assessed by reviewing the number of adverse events and overall toxicity.

Secondary Endpoints
efficacy
Efficacy will be measured every 8-12 weeks during treatment and every 6 months during the 2nd year and then annually up to 5 years thereafter.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IMMU-130EXPERIMENTAL -
Interventions
NameTypeDescription
IMMU-130DRUGIMMU-130 will be administered intravenously every 2 weeks for up to 6 months or longer.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female patients, \>18 years of age, able to understand and give written informed consent. * Histologically or cytologically confirmed colorectal adenocarcinoma. * Stage IV (metastatic) disease. * Failed at least one prior standard treatment regimen for colorectal cance...

Countries:United States
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Competitive Landscape -Colorectal Cancer 263 trials
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