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Clinical Trial 18321

Cancer Type: Thoracic
Interventions:PBF-509; PDR001 (Spartalizumab)

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Alberto Chiappori

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Phase I/Ib trial of single agent PBF-509 and in combination with PDR001 for patients with advanced NSCLC

Summary

The purpose of this study is to determine the safety, tolerability and feasibility of an adenosine A2a receptor antagonist (PBF-509) during a phase I dose escalation trial in advanced or metastatic non-small cell lung cancer (NSCLC) patients.

Objective

Primary Objective: To determine the safety, tolerability and feasibility of PBF-509 during a phase I dose escalation trial. Secondary Objectives: 1. Determine the pharmacokinetic profile of PBF-509. 2. Determine the safety profile of PBF-509. 3. Response rate and duration, and survival.

Inclusion Criteria

  • Histological or cytological diagnosis of non-small cell lung cancer (NSCLC)
  • Progressed on or intolerant to a platinum-containing doublet
  • No limits to the prior lines of treatment
  • Epidermal growth factor receptor (EGFR) mutation with deletion 19 or L858R mutation (Exon 21) or anaplastic lymphoma kinase (ALK) rearrangement positive must have failed prior TKI therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0/1
  • Age greater than 18 years
  • Adequate bone marrow, renal and hepatic function
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Able and willing to give valid written consent for available archival tumor samples (not mandatory) and tumor biopsies before and during protocol (immune)therapy (mandatory).
  • Prior immunotherapy is allowed, except for the participants enrolled to the immunotherapy naïve group of the phase iB dose expansion.
  • Written informed consent and any locally-required authorization obtained from the participant prior to performing any protocol-related procedures, including screening evaluations
  • Willing and able to comply with the protocol for the duration of the study
  • Female participants must either be of non-reproductive potential or have to use non-hormonal contraceptive measures with spermicide or condom.
  • Additional criteria may apply

    • Exclusion Criteria

  • Symptomatic and/or untreated Brain Metastases
  • Pregnancy or breast feeding
  • Serious uncontrolled medical disorder or active infection that would impair the participant's ability to receive study treatment
  • Concurrent use of other anticancer approved or investigational agents
  • Autoimmune disorder
  • Prior malignancy in past 2 years
  • 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)
  • Concurrent administration of strong inhibitors or moderate inducers of CYP1A2 is not permitted; administration must be discontinued at least 7 days prior to initiating study drug administration
  • Additional criteria may apply

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