PTX-35 in Patients With Advanced Solid Tumors

Exclusion Criteria

• •In order to participate in this study, a patient must not:
• •1. Have received any systemic anticancer therapy including small molecules, chemotherapy, radiation therapy, monoclonal antibodies or any other experimental drug within 4 weeks of first dose of PTX-35. Adjuvant anti hormonal treatment(s) for prior breast cancer or prostate cancer are allowed. (Note: washout for palliative radiation therapy is 2 weeks).
• •2. Have clinically significant cardiac disease, including:
• •1. Onset of unstable angina within 6 months of signing the Informed Consent Form (ICF).
• •2. Acute myocardial infarction within 6 months of the signing the ICF.
• •3. Known congestive heart failure (Grade III or IV as classified by the New York Heart Association); and/ or a known decreased cardiac ejection fraction (LVEF) of \< 45%.
• •4. Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg, despite optimal medical management.
• •3. Have known or clinically suspected leptomeningeal disease. Stable, previously treated metastases in the brain or spinal cord, are allowed as long as these are considered stable (by CT or MRI), and not requiring systemic corticosteroids.
• •4. Have a history of ≥ Grade 3 allergic reactions, or suspected allergy or intolerance to monoclonal antibody therapies.
• •5. Have a history of suspected cytokine release syndrome (CRS).
• •6. Have any known immunodeficiency disorders (testing not required).
• •7. Have received prior allogeneic stem cell transplant.
• •8. Have ongoing or current autoimmune disease. Permanent but stable and manageable immune related adverse events (irAE) from prior therapies are permissible, if prednisone equivalent corticosteroid use does not exceed 10 mg/day.
• •9. Have any other condition requiring concurrent systemic immunosuppressive therapy (other than allowable exceptions which do not exceed 10mg/day of prednisone/corticosteroid use).
• •10. Have clinically significant active viral, bacterial or fungal infection requiring:
• •1. Intravenous treatment with antimicrobial therapy completed less than two weeks prior to first dose, or
• •2. Oral treatment with antimicrobial therapy completed less than one week prior to first dose. Prophylactic treatment with antibiotics (e.g. for dental extractions) is allowed.
• •11. Have had major surgery (requiring general anesthesia or inpatient hospitalization) within four weeks before first administration of PTX-35.
• •12. Have had a known tetanus/diphtheria vaccine within the past 10 years.
• •13. Have known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least two years.
• •14. Have known previously untreated or symptomatic metastases in the brain or spinal cord requiring steroids. Patients with treated and stable CNS metastases may be enrolled after approval of the sponsor and/or Medical Monitor.
• •15. Have any other ongoing significant, uncontrolled medical condition in the opinion of the Investigator.
• •16. Have known positive serology for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C (except in cases of immunity after cured infection). Testing not required.
• •17. Have a history of substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the trial or evaluation of the trial result.
• •18. Be a female patient who is pregnant or breast feeding.