ClinicalTrialsFinder
CompletedPhase 1ACTRN12610000733077

PAT-SM6 in Patients with Recurrent In-Transit Cutaneous Melanoma

A Single Dose, Dose Escalating, Phase I Clinical Trial to Determine the Safety of a Single Dose of PAT-SM6 Monoclonal Antibody in Patients with Recurrent In-Transit Cutaneous Melanoma

Sponsor

Patrys Limited

Enrollment

9 participants

Start Date

Aug 27, 2010

Study Type

Interventional

Conditions

Recurrent in-transit cutaneous melanoma

Summary

This study looks at the effectiveness and safety of a single dose of PAT-SM6 in treating people with melanoma of the skin. Who is it for? You may be able to join this study if you have locally recurring cutaneous (skin) melanoma. You must not have received chemotherapy or therapeutic radiotherapy in the previous 28 days. You will be required to have a biopsy sample of the melanoma prior to receiving study medication. Trial details: Participants will all receive a single dose of human anti-GRP78 IgM monoclonal antibody PAT-SM6 via intravenous infusion over 60 minutes, at varying doses. They will return to the site on day 4 for another biopsy of the melanoma/surgery. Patients will remain on study for 5 weeks. The study aims to monitor the safety and effectiveness of treatment. What is PAT-SM6? PAT-SM6 is different to other antibodies on the market for cancer because it a naturally-occurring human molecule. It fights tumours by fixing on to specific targets on cancerous cells and killing them.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests an experimental antibody treatment (PAT-SM6) for adults with recurring melanoma skin cancer that has spread between the original site and nearby lymph nodes (in-transit melanoma). You must be 18 or older, have confirmed melanoma, and be willing to provide tumour biopsies. People with advanced metastatic disease, uncontrolled medical conditions, or who are HIV-positive cannot participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

A single dose of Human anti-GRP78 Immunoglobulin M (IgM) monoclonal antibody PAT-SM6 via intravenous infusion over 60 minutes. The initial cohort of 3 patients will receive 0.15mg/kg, the second cohor

A single dose of Human anti-GRP78 Immunoglobulin M (IgM) monoclonal antibody PAT-SM6 via intravenous infusion over 60 minutes. The initial cohort of 3 patients will receive 0.15mg/kg, the second cohort will receive 0.3mg/kg and the final cohort will receive 0.6mg/kg.

Locations(1)

SA, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12610000733077