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

NCT02403193 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2022-01-12

No results posted yet for this 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.

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Interventions

DRUG

PBF-509_80 mg

PBF-509: 80 mg, PO, twice daily (BID)

DRUG

PBF-509_160 mg

PBF-509: 160 mg, PO, twice daily (BID)

DRUG

PBF-509_320 mg

PBF-509: 320 mg, PO, twice daily (BID)

DRUG

PBF-509_640 mg

PBF-509: 640 mg, PO, twice daily (BID)

DRUG

Combo PBF-509 (160 mg) + PDR001

Drug 1: PDR001 administered intravenously. Drug 2: PBF-509 administered orally

DRUG

Combo PBF-509 (320 mg) + PDR001

Drug 1: PDR001 administered intravenously. Drug 2: PBF-509 administered orally

DRUG

Combo PBF-509 (640 mg) + PDR001

Drug 1: PDR001 administered intravenously. Drug 2: PBF-509 administered orally

DRUG

RP2D (PBF-509+PDR001)_immuno naïve

Drug 1: PDR001 administered intravenously. Drug 2: PBF509 administered orally

DRUG

Experimental: RP2D (PBF-509+PDR001)_immuno treated

Drug 1: PDR001 administered intravenously. Drug 2: PBF509 administered orally

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    collaborator OTHER

  • Palobiofarma SL

    lead INDUSTRY

Principal Investigators

  • Alberto Chiappori, MD · Moffitt Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2021-10-31
Completion
2021-11-24

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02403193 on ClinicalTrials.gov