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188Re-PTI-6D2

Phase 1

Metastatic Melanoma | Small molecule | Oncology |Filana Therapeutics, Inc.|Last Updated: Jul 14, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

188Re-PTI-6D2 · 1 trial · 1 indication

Phase 1 1
NCT00399113Safety Study of 188Re-PTI-6D2 in Patients With Metastatic MelanomaMetastatic Melanoma
COMPLETED12 Analytics
PHASE1COMPLETED
Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
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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 to 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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Frequently asked questions about 188Re-PTI-6D2

What is 188Re-PTI-6D2 used for?

188Re-PTI-6D2 is an investigational small molecule being developed for the treatment of metastatic melanoma. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients.

Who makes 188Re-PTI-6D2?

188Re-PTI-6D2 is being developed by Cassava Sciences, Inc., a biopharmaceutical company. The company is conducting clinical research on this investigational drug for metastatic melanoma.

What phase is 188Re-PTI-6D2 in?

188Re-PTI-6D2 is in Phase 1 clinical development. A Phase 1 trial has been completed, which was an uncontrolled, non-randomized study designed to evaluate the safety of the drug in patients with metastatic melanoma.

What clinical trials is 188Re-PTI-6D2 in?

188Re-PTI-6D2 has one completed clinical trial, identified as NCT00399113, titled "Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma." This Phase 1 study enrolled 12 patients in Israel and included adults aged 18 years and older.

Is 188Re-PTI-6D2 FDA approved?

188Re-PTI-6D2 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for metastatic melanoma. The drug has completed a Phase 1 safety study, but it has not yet received regulatory approval for any use.