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188Re-PTI-6D2

Phase 1

Metastatic Melanoma | Small molecule | Oncology |Cassava Sciences, Inc.|Last Updated: Jul 14, 2011

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 Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00399113Safety Study of 188Re-PTI-6D2 in Patients With Metastatic MelanomaPHASE1 COMPLETED 12 — — May 1, 2007 -Jul 14, 20112 Israel
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Study Endpoints
Primary Endpoints
To select the amount of unlabeled PTI-6D2 to administer immediately prior to a tracer dose of 188Re-PTI-6D2 in order to achieve preferred tumor targeting
To generate pharmacokinetic (PK) and biodistribution data of 188Re-PTI-6D2 in patients with metastatic melanoma in order to estimate radiation doses absorbed to tumor and critical organs
To determine the frequency of HAMA response associated with 188Re-PTI-6D2 administration
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
188Re-PTI-6D2DRUGmonoclonal antibody
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Histologically confirmed Stage IIIc (unresectable) or Stage IV metastatic melanoma; * measurable disease; * at least 18 years of age; * Karnofsky status at least 50%; * life expectancy \> 3 months; * at least 4 weeks since prior therapy; * adequate organ and marrow function de...

Countries:Israel
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Competitive Landscape -Melanoma 127 trials
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