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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 Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00734188Dose Escalation and Safety Study of 188Re-PTI-6D2 in Patients With Metastatic MelanomaPHASE1 COMPLETED 21Jan 1, 2009Jun 1, 2010Jul 14, 20111 Israel
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Study Endpoints
Primary Endpoints
To determine the maximum tolerated dose (MTD) of 188Re-PTI-6D2 in patients with metastatic melanoma
Daily/Weekly/Monthy
Secondary Endpoints
to determine safety and tolerability; dose-limiting toxicities; evaluate the anti-tumor activity; to evaluate the HAMA response; and, to further characterize the pharmacokinetics, biodistribution, and dosimetry of 188Re-PTI-6D2
Daily/Weekly/Monthly
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
PTI-6D2DRUGmonoclonal antibody
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients must have histologically or clinically confirmed malignant melanoma of one of the following stages (according to 2002 American Joint Committee on Cancer criteria: Appendix C): Unresectable Stage III disease or Stage IV disease * Patients must have measurable disease a...

Countries:Israel
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