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SGN-75

Phase 1

Carcinoma, Renal Cell | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Dec 18, 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 Enrollment58
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01015911A Phase 1 Dose-escalation Trial of SGN-75 in CD70-positive Non-Hodgkin Lymphoma or Renal Cell CarcinomaPHASE1 COMPLETED 58Nov 1, 2009Mar 1, 2012Dec 18, 20149 United States
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Study Endpoints
Primary Endpoints
Incidence of adverse events and laboratory abnormalities
Through 1 month following last dose
Secondary Endpoints
Best clinical response
Every 2 months
Duration of response, progression-free survival
Every 3 months until progression of disease or initiation of new treatment for cancer
Blood concentrations of SGN-75 and metabolites
Through 1 month following last dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALSGN-75
Interventions
NameTypeDescription
SGN-75DRUGSGN-75 (IV) in 21- or 28-day cycles; dose range: 0.3-9 mg/kg
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Pathologically-confirmed diagnosis of NHL or RCC * Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy * Confirmed CD70 expression * Measurable disease, defined as at least 1 lesion \>1.5 cm in the greatest transverse diameter for patients ...

Countries:United States
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