None listed
Conditions
Brief 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.
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 cohort will receive 0.3mg/kg and the final cohort will receive 0.6mg/kg.
Sponsors
Patrys Limited
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient has recurrent in-transit cutaneous melanoma based on diagnosis by cytology or histology. The patient may or may not have asymptomatic distant metastatic disease limited to Stage M1a. 2. The patient is willing and able to provide a pre- and post-treatment tumour biopsy. 3. The patient has an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1 or 2 at study entry. 4. The patient has provided written informed consent. 5. The patient is age 18 years or older. 6. The patient has a life expectancy of > 3 months. 7. The patient has adequate hematologic function, as defined by: - an absolute neutrophil count >= 1500/mm3 - a platelet count >= 100,000/mm3 8. The patient has a haemoglobin level >9 g/dL. 9. The patient has adequate hepatic function, as defined by: - a total bilirubin level <= the upper limit of normal (ULN) unless due to congenital Gilbert’s syndrome - aspartate transaminase (AST) and alanine transaminase (ALT) levels <= 2.5 x the ULN 10. The patient has adequate renal function, with calculated creatinine clearance (using Cockcroft Gault formula) of >50 mL/min and 0 to 1+ proteinuria. 11. The patient uses effective contraception (per the institutional standard), if procreative potential exists. 12. The patient has adequately recovered from any recent therapy, including surgery, chemotherapy, and radiation therapy. 13. The patient is accessible for treatment and follow-up at the participating centre.
Exclusion criteria
1. The patient has metastatic disease at Stage M1b (lung metastases with normal LDH of <=ULN) or M1c (other distant metastases or any distant metastases with elevated LDH of >ULN). 2. The patient has received chemotherapy or therapeutic radiotherapy within 28 days prior to the first dose of study medication or has ongoing side effects >= Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.0) Grade 2 due to agents administered more than 28 days earlier. 3. Immunosuppressive therapy including corticosteroids within four weeks of screening; 4. The patient has uncontrolled intercurrent illness including, but not limited to: - ongoing or active infection requiring parenteral antibiotics, - symptomatic congestive heart failure (class III or IV of the New York Heart Association classification for heart disease), - unstable angina pectoris, angioplasty, stenting, or myocardial infarction six months prior to the first dose of study medication, - uncontrolled hypertension (systolic blood pressure >160 mmHg, diastolic blood pressure >100 mmHg, found on two consecutive measurements separated by a one week period despite adequate medical support), - clinically significant cardiac arrhythmia including but not limited to: multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment, CTCAE, Version 4.0, Grade 3, or asymptomatic sustained ventricular tachycardia, - uncontrolled diabetes, - psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements, 5. The patient has known human immunodeficiency virus positivity. 6. The patient has had a major surgical procedure or a significant traumatic injury within 28 days prior to treatment. 7. The patient is currently or has recently used (within 28 days prior to) a thrombolytic agent. 8. The patient is currently using full-dose warfarin (an exception is low-dose warfarin to maintain patency of pre-existing, permanent, indwelling intravenous catheters; for patients receiving warfarin, the international normalised ratio [INR] should be <1.5). A patient requiring heparin is excluded. A patient receiving antiplatelet agents such as non-steroidal anti-inflammatory drugs including aspirin, clopidogrel and dipyramidole is excluded. 9. Known hemorrhagic diathesis or active bleeding disorder. 10. The patient has any condition, which in the Investigator’s opinion, puts the patient at significant risk, could confound study results, or may interfere with the patient’s participation in the study. 11. The patient has received an Investigational Product within 30 days prior to dosing, or five half-lives of the drug whichever is longer. 12. The patient has a QTc interval of greater than 450 ms (males) and 470 ms (females).
Outcome results
None listed