CompletedPhase 1NCT02403193
Official study title

Trial of PBF-509 and PDR001 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Study summary

The purpose of this study is to determine the safety, tolerability, feasibility and preliminary efficacy of the administration of PBF-509 (Adenosine A2a receptor antagonist) as single agent or in combination with PDR001 (programmed cell death 1 receptor antibody (PD-1 Ab)) to NSCLC patients.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPBF-509_80 mg and PBF-509_160 mg

Plus 7 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 12, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Palobiofarma SL

Study sponsor

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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Palobiofarma SL
Interventions being studied
Drug: PBF-509_80 mg; Drug: PBF-509_160 mg; Drug: PBF-509_320 mg; Drug: PBF-509_640 mg; Drug: Combo PBF-509 (160 mg) + PDR001; Drug: Combo PBF-509 (320 mg) + PDR001; Drug: Combo PBF-509 (640 mg) + PDR001; Drug: RP2D (PBF-509+PDR001)_immuno naïve; Drug: Experimental: RP2D (PBF-509+PDR001)_immuno treated
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Patients must have histologic or cytologic diagnosis of advanced/metastatic NSCLC. For those with mixed histology, there must be a predominant histology. 2. Patients must previously have received at least one prior line of therapy for their disease 3. EGFR mutation with exon 19 deletion or L858R mutation (Exon 21) or ALK rearrangement positive must have failed prior TKI therapy 4. Able, willing to give written consent for available archival tumor samples (not mandatory) and tumor biopsies before and during protocol therapy (mandatory). 5. Prior immunotherapy is allowed (previous immune checkpoint inhibitors; anti-CTLA-4, anti-PD-1, anti-PD-L1 and/or combinations), except for the patients enrolled to the immunotherapy naïve group of the phase IB dose expansion. 6. Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>20 mm with conventional techniques or as \>10 mm with spiral computed tomography (CT) scan, Magnetic resonance imaging (MRI), or calipers by clinical exam. See Section 13. 7. Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations 8. Age \> 18 years at time of study entry 9. Eastern Cooperative Oncology Group (ECOG) 0-1 10. Adequate normal organ and marrow function 11. Female patients must either be of non-reproductive potential (ie, post-menopausal by history: ≥60 years old or no menses for 1 year without an alternative medical cause; OR history of complete hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry. 12. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use 2 highly effective methods of contraception while taking study treatment and for 90 days after the last dose of study treatment. 13. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Reasons someone may not be able to joinExclusion criteria

1. Symptomatic and/or untreated Brain Metastases 2. Pregnancy or breast feeding 3. Serious uncontrolled medical disorder or active infection that in the investigator's opinion would impair the patient's ability to receive study treatment. 4. Concurrent use of other anticancer approved or investigational agents is not allowed. 5. 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. 6. Prior malignancy in past 2 years or as identified in Section 7.2 of this protocol 7. Patients receiving systemic steroids ≥ 10mg/day of prednisone or the equivalent 8. 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) 9. 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • H.Lee Moffitt Cancer centerTampa, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 12, 2022. Always confirm current availability with the study team.

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