None listed
Conditions
Brief summary
The purpose of this study is to investigate whether a new drug called PIN-2 is safe and activates the immune system in patients with advanced solid tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a histologic diagnosis of an advanced solid tumor. Study details All participants in this study will receive one cycle of chemotherapy treatment with the drug, PIN-2 (Precision Immune Stimulants). PIN-2 will be administered intravenously (i.e. directly into the vein) 3 x per week for 2 weeks followed by a one week rest period. If tolerated and deemed beneficial, a second identical course may be administered. No more than 2 courses in total will be given. Participants will be regularly monitored for safety, and asked to provide a number of blood samples across a 5 week period to assess how the body processes and responds to the drug. Tissue samples (tumor and/or lymph node) will also be obtained, if possible, at pre-treatment and again at the conclusion of each treatment cycle for evaluation. Patients who are eligible for and agree to participate in the biopsy will have tumor biopsy prior to treatment and at week 3. This study will help find new methods of treatment for the patients with solid tumors.
Interventions
Approximately 6-8 subjects with advanced solid tumors will be enrolled to receive one cycle of PIN-2 treatment (administered intravenously) consisting of 300 µg PIN-2, 3x per week (Day1, Day3 and Day5 of the week) for 2 weeks followed by a one week rest period. Patient who do not experience >grade 2 toxicity and in the opinion of the Investigator may benefit from a second course can receive a second course of 2 weeks treatment following a one week rest period on the same schedule as above, apart
Approximately 6-8 subjects with advanced solid tumors will be enrolled to receive one cycle of PIN-2 treatment (administered intravenously) consisting of 300 µg PIN-2, 3x per week (Day1, Day3 and Day5 of the week) for 2 weeks followed by a one week rest period. Patient who do not experience >grade 2 toxicity and in the opinion of the Investigator may benefit from a second course can receive a second course of 2 weeks treatment following a one week rest period on the same schedule as above, apart from tumor biopsies which may be performed at the discretion of the investigator. The second cycle will be given at the same dose. No dose escalation or dose reduction is permitted. No more than 2 courses will be given. PD samples will be obtained on the last day of dosing. NCI CTCAE v4.0 toxicity grading scale will be used. No intervention adherence will be assessed.
Sponsors
PIN Pharma Pty Ltd
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. Male or female subjects greater than equal to 18 years with a histologic diagnosis of an advanced solid tumor. 2. Women of childbearing potential and men must agree to use highly effective, double barrier contraception during the study and for 6 weeks following the final dose of PIN-2. Double barrier contraception is defined as a condom AND one other form of the following: a. Birth control pills (The Pill) b. Depot or injectable birth control c. IUD (Intrauterine Device) d. Birth control patch (e.g. Ortho Evra) e. NuvaRing® f. Documented evidence of surgical sterilization at least 6 months prior to the screening visit, i.e., tubal ligation or hysterectomy for women or vasectomy for men. Biopsy: Presence of a lesion amenable to biopsy. Patients do not need to have a lesion that can be biopsied in order to be eligible for the study. The biopsy is optional to the patient.
Exclusion criteria
1. Unable or unwilling to sign informed consent. 2. Fewer than 500 monocytes/µL as determined by CBC. 3. Fewer than 800 lymphocytes/µL as determined by CBC. 4. Any chemotherapy, immunotherapy or radiation therapy within 4 weeks prior to treatment. 5. Expected survival <90 days. 6. Any residual toxicity >Common Terminology Criteria for Adverse Events (CTCAE) 4.0 greater than equal to grade 2. 7. Clinically active infection on antibiotic therapy within 72h prior to treatment. 8. Any medical or psychiatric condition that would, in the opinion of the investigator, make it difficult for the subject to comply with study activities. 9. Any unstable medical or psychiatric condition. 10. Ongoing use of systemic corticosteroids or immunosuppressive agents. 11. Any immunodeficiency syndrome, including HIV infection. 12. Current brain or spinal cord metastasis. 13. Evidence of significant damage to liver (transaminases, >2.5 upper limit of normal [ULN], bilirubin>ULN), kidney (creatinine >1.25xULN), heart (MI or PCI within 6 months, unstable angina pectoris), or bone marrow (Hb<9 gm/dL, WBC <1500/µL, platelet <100,000/µL). 14. Evidence of ongoing autoimmunity from checkpoint inhibitor or other therapy (except vitiligo or endocrinopathy stable on replacement therapy) 15. Compromised or inadequate venous access 16. Pregnant or lactating women 17. Patients with tuberculosis or viral hepatitis
Outcome results
None listed