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SGN-CD19A

Phase 1

Burkitt Lymphoma | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Oct 19, 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 Trials2
Total Enrollment156
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01786096A Safety Study of SGN-CD19A for Leukemia and LymphomaPHASE1 COMPLETED 92 — — Feb 1, 2013May 30, 2017Jul 2, 201713 United States
NCT01786135A Safety Study of SGN-CD19A for B-Cell LymphomaPHASE1 COMPLETED 64 — — Feb 1, 2013Feb 16, 2017Oct 19, 20176 United States
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Study Endpoints
Primary Endpoints
Incidence of adverse events
Through 1 month post last dose
Incidence of laboratory abnormalities
Through 1 month post last dose
Secondary Endpoints
Objective response according to modified response criteria for acute myeloid leukemia (Cheson 2003) or revised response criteria for malignant lymphoma (Cheson 2007)
Through 1 month post last dose
Duration of response
Until disease progression or start of new anticancer treatment, an expected average of 3 months
Overall survival
Until death or study closure, an expected average of 6 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SGN-CD19AEXPERIMENTALSGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg
Interventions
NameTypeDescription
SGN-CD19ADRUGSGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg
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Eligibility Criteria
Age Range1 Year — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Adult patients must be relapsed or refractory to at least 1 prior multi-agent systemic therapy. Pediatric patients must be relapsed or refractory to at least 2 prior multi-agent systemic therapies. Patients with acute lymphoblastic leukemia who are Philadelphia chromosome-posi...

Countries:United States
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