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IPH2101 combined to lenalidomide

Phase 1

Patients With Multiple Myeloma Experiencing a | Small molecule | Oncology |Innate Pharma S.A.|Last Updated: Feb 28, 2014

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
NCT01217203Study on the Safety, Anti-tumor Activity and Pharmacology of IPH2101 Combined With Lenalidomide in Patients With Multiple Myeloma Experiencing a First or Second RelapsePHASE1 COMPLETED 15Sep 1, 2010Feb 1, 2014Feb 28, 20146 United States
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Study Endpoints
Primary Endpoints
number of patients with Dose Limiting Toxicity (DLT) at each dose level
1 year

safety of IPH2101 combined with lenalidomide at different dose levels.

Secondary Endpoints
To assess response rate of the combination
1 year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IPH2101 and lenalinomideEXPERIMENTAL -
Interventions
NameTypeDescription
IPH2101 combined to lenalidomideDRUGDose level 1 : 0.2 mg/kg IPH2101(with Lenalidomide 10 mg/day) Dose level 2 : 0.2 mg/kg IPH2101(with Lenalidomide 25 mg/day) Dose level 3 : 1 mg/kg IPH2101(with Lenalidomide 25 mg/day) Dose level 4 : 2 mg/kg IPH2101(with Lenalidomide 25 mg/day) Extension cohort: 6 patients at the Maximum Tolerated Dose (MTD)
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Signed informed consent obtained before any trial-related activities 2. Progressive disease or relapse of multiple myeloma (according to the IMWG definition) after one or two prior therapeutic treatments or regimens for multiple myeloma that achieved a response duration of at...

Countries:United States
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