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188Re-PTI-6D2

Phase 1

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

188Re-PTI-6D2 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2001

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

188Re-PTI-6D2 clinical trials

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
Metastatic MelanomaUnlock trial analytics

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?

188Re-PTI-6D2 is an investigational small molecule therapeutic being developed by Filana Therapeutics, Inc. for metastatic melanoma. It is a Phase 1-stage oncology asset that has been studied in a single completed clinical trial. It is not an approved product and remains in clinical development.

What is 188Re-PTI-6D2 used for in metastatic melanoma?

188Re-PTI-6D2 was studied as a treatment for patients with metastatic melanoma, an advanced form of skin cancer that has spread beyond the original site. The only clinical trial of this agent enrolled adults 18 years and older with metastatic melanoma. It is investigational and has not been approved for any use.

Who makes 188Re-PTI-6D2?

188Re-PTI-6D2 is being developed by Filana Therapeutics, Inc., which trades under the ticker FLNA. Filana Therapeutics is the sponsor of the clinical program for this metastatic melanoma candidate. No other developer or partner is associated with the asset based on its public development record.

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

188Re-PTI-6D2 is in Phase 1 development. Its single clinical trial, NCT00399113, was a Phase 1 safety study in metastatic melanoma and is now completed. The program has no active trials, and the drug is investigational rather than approved.

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

188Re-PTI-6D2 has been evaluated in one clinical trial, NCT00399113, titled Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma. That Phase 1 trial was completed and enrolled 12 participants in Israel. It was an uncontrolled study open to all sexes, with no healthy volunteers.

Is 188Re-PTI-6D2 approved by the FDA?

188Re-PTI-6D2 is not approved. It is an investigational agent that has completed a single Phase 1 safety trial in metastatic melanoma, and no regulatory approval has been granted for this candidate. Further clinical development would be required before any approval could be considered.