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

Phase 1 Completed 92 enrolled Palobiofarma SL H. Lee Moffitt Cancer Center and Research Institute · collab Novartis · collab

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2015-10
Primary completion: 2021-10
Completion: 2021-11-24

Publications

Chiappori AA, Creelan B, Tanvetyanon T, Gray JE, Haura EB, Thapa R, Barlow ML, Chen Z, Chen DT, Beg AA, Boyle TA, Castro J, Morgan L, Morris E, Aregay M, Hurtado FK, Manenti L, Antonia S. Phase I Study of Taminadenant (PBF509/NIR178), an Adenosine 2A Receptor Antagonist, with or without Spartalizumab (PDR001), in Patients with Advanced Non-Small Cell Lung Cancer. Clin Cancer Res. 2022 Jun 1;28(11):2313-2320. doi: 10.1158/1078-0432.CCR-21-2742.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NIR178	Unknown	80 mg	Oral
Subject	NIR178	Unknown	160 mg	Oral
Subject	NIR178	Unknown	320 mg	Oral
Subject	NIR178	Unknown	640 mg	Oral
Subject	Spartalizumab	Monoclonal antibody	400 mg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications