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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 Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

PTI-6D2 · 1 trial · 1 indication

Phase 1 1
NCT00734188Dose Escalation and Safety Study of 188Re-PTI-6D2 in Patients With Metastatic MelanomaMetastatic Melanoma
COMPLETED21 Analytics
PHASE1COMPLETED
Dose Escalation and Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
Metastatic MelanomaUnlock trial analytics

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 to 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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Frequently asked questions about PTI-6D2

What is PTI-6D2 used for?

PTI-6D2 is an investigational small molecule being studied for the treatment of metastatic melanoma. It is a radiopharmaceutical agent that has been evaluated in a Phase 1 clinical trial. The drug is not approved and remains in clinical development.

What does PTI-6D2 target?

PTI-6D2 is a radiopharmaceutical that delivers a radioactive isotope, rhenium-188, to cancer cells. It is designed to target and bind to melanoma cells, allowing for targeted radiation therapy. The specific molecular target has not been disclosed.

Who is developing PTI-6D2?

PTI-6D2 is being developed by Cassava Sciences, Inc., a biopharmaceutical company. The company conducted a Phase 1 clinical trial of the drug in patients with metastatic melanoma. Cassava Sciences is publicly traded under the ticker symbol FLNA.

What phase is PTI-6D2 in?

PTI-6D2 is in Phase 1 clinical development. A Phase 1 dose escalation and safety study has been completed. The drug is investigational and has not received regulatory approval for any use.

What clinical trials is PTI-6D2 in?

PTI-6D2 has been studied in one clinical trial, NCT00734188, titled "Dose Escalation and Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma." This Phase 1 trial enrolled 21 participants in Israel and has been completed.

Is PTI-6D2 the same as 188Re-PTI-6D2?

Yes, PTI-6D2 is also known as 188Re-PTI-6D2, which refers to the drug labeled with the radioactive isotope rhenium-188. The clinical trial NCT00734188 used this name to describe the investigational agent.