PBF-1129 in Patients With NSCLC

Exclusion Criteria

• •Participation in another clinical study with an investigational product during the last 4 weeks or 5 half-lives prior to starting on treatment.
• •Symptomatic and/or untreated or actively progressing central nervous system (CNS) metastases or leptomeningeal disease. Patients with a history of treated CNS metastases are eligible, provided that all of the following criteria are met:
• •* The patient has not received stereotactic radiotherapy within 7 days prior to initiation of study treatment or whole-brain radiotherapy within 14 days prior to initiation of study treatment.
• •* The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anti-convulsant therapy at a stable dose is permitted.
• •Serious uncontrolled medical disorder or active infection that would impair the patient's ability to receive study treatment.
• •Concurrent use of other anticancer approved or investigational agents is not allowed.
• •Autoimmune disorder
• •Prior malignancy in past 2 years or as identified in Section 7.2 of this protocol
• •Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
• •Patients receiving systemic steroids ≥ 10mg/day of prednisone or the equivalent
• •Smoking (cigarettes, cigars or pipes) must be discontinued at least 7 days prior to initiating study drug administration; smoking cessation products (transdermal nicotine patches or chewing gum may be used.
• •Pregnancy or breastfeeding, or intention of becoming pregnant during the study. Female subjects must either be of non-reproductive potential or have a negative serum pregnancy test result within 14 days prior to initiation of study treatment