PBF-1129 in Patients With NSCLC

Inclusion Criteria

• Histological or cytological diagnosis of metastatic squamous or non-squamous NSCLC.
• Life expectancy greater or equal to 3 months, as determined by the investigator -Patients must have progressed on the standard therapy, including platinum based - chemotherapy. Patients with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations must have progressed on standard treatment options including EGFR, ALK, or ROS-1-directed therapies.
• No limits to the prior lines of treatment
• ECOG performance status of 0/1
• Measurable Disease by RECIST v1.1
• Age greater than 18 years.
• Adequate bone marrow, renal and hepatic function:
• Absolute neutrophil count (ANC) ≥ 1500 /µL
• White blood cell count (WBC) t ≥ 2.5 x 109/L (2500/µL)
• Lymphocyte count ≥ 0.5 x 109/L (500/µL)
• Platelet count ≥ 100 x 109/L (100,000/µL) without transfusion
• Hemoglobin ≥ (9.0 g/dL) - patients may be transfused to meet this criterion.
• Aspartate aminotransferase AST, alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN)
• Serum bilirubin ≤ 1.5 x ULN, with the exception of patients with known Gilbert disease: serum bilirubin level ≤ 3 x ULN
• Creatinine clearance >60 mL/min (calculated using the Cockcroft-Gault formula) or by 24-hours urine collection
• Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
• Subject is willing and able to comply with the protocol for the duration of the study

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