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PBF-1129 in Patients With NSCLC

Trial Status: Active

Phase I clinical trial in Eastern Cooperative Oncology Group (ECOG) 0-1 patients with locally advanced or metastatic NSCLC to evaluate safety and tolerability of the compound PBF-1129, an Adenosine A2b receptor antagonist. The phase I dose escalation will be conducted 3+3 method. Pharmacokinetic (PK) data will be also obtained.

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

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Palobiofarma SL

  • Primary ID PBF-1129CT_03
  • Secondary IDs NCI-2018-00709
  • Clinicaltrials.gov ID NCT03274479