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HuMax-IL8

Phase 1

Solid Tumor | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Feb 3, 2017

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 Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02536469HuMax-IL8 (Interleukin8) in Patients With Advanced Malignant Solid TumorsPHASE1 COMPLETED 15Aug 1, 2015Nov 1, 2016Feb 3, 20171 United States
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Study Endpoints
Primary Endpoints
Proportion of patients who experience DLTs (Dose Limiting Toxicity) 28 days following the first dose of HuMax-IL8, as well as all DLTs occurring during the study thereafter.
From cycle 1 day 1 up to 28 days

The primary endpoint of this study is the proportion of patients who experience DLTs. The MTD (Maximum Tolerated Dose) will be determined based on the dose escalation cohorts. The evaluation period for DLTs will be 28 days following the first dose of HuMax-IL8

Secondary Endpoints
Pharmacokinetic properties of HuMax-IL8 in patients including AUC (Area Under the Curve)
From baseline up to 72 hours after infusion
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
HuMax-IL8EXPERIMENTALHuMax-IL8 drug product intended for intravenous infusion. Subjects will be treated every 2 weeks. Every 2 doses (4 weeks) will be considered 1 cycle
Interventions
NameTypeDescription
HuMax-IL8DRUGHuMax-IL8 drug product intended for intravenous infusion. Subjects will be treated every 2 weeks. Every 2 doses (4 weeks) will be considered 1 cycle
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects must have metastatic or unresectable locally advanced malignant solid tumor. * Patients may have measurable or non-measurable but evaluable disease. * Patients with surgically resected metastatic disease at high risk of relapse are also eligible. * Patients must have ...

Countries:United States
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