PBF-1129 in Patients With NSCLC

Phase I Trial of PBF-1129 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

NCT03274479•Palobiofarma SL

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 A2b receptor antagonist. The phase I dose escalation will be conducted 3+3 method. Pharmacokinetic (PK) data will be also obtained.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)
+7 more criteria

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
+2 more criteria

Locations (1)

Division of medical Oncology A450B Starling Loving Hall

Ohio City, Ohio, United States

Key Dates

Start Date

October 1, 2018

Primary Completion Date

May 1, 2024

Completion Date

August 1, 2024

Last Updated

February 9, 2024

Enrollment

ESTIMATED participants

Conditions

Locally Advanced or Metastatic NSCLC

Interventions

PBF-1129

DRUG