Status:
ACTIVE_NOT_RECRUITING
PBF-1129 in Patients With NSCLC
Lead Sponsor:
Palobiofarma SL
Collaborating Sponsors:
Ohio State University
Conditions:
Locally Advanced or Metastatic NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 A2...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03274479
Start Date
October 1 2018
End Date
August 1 2024
Last Update
February 9 2024
Active Locations (1)
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1
Division of medical Oncology A450B Starling Loving Hall
Ohio City, Ohio, United States, 43210