PBF-1129 in Patients With NSCLC

Phase 1 Unknown 18 enrolled Palobiofarma SL Ohio State University · collab

Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start: 2018-10-01
Primary completion: 2024-05-01
Completion: 2024-08-01

Publications

Owen DH, Wu R, Wei L, Dikov M, Suman S, Su PL, Amann J, Guan S, Spakowicz D, Schweitzer C, Pilcher C, Smith MB, Ferguson S, Palomino JC, Perez SF, Bertino EM, Shields PG, He K, Presley CJ, Otterson GA, Carson WE, Carbone DP. Phase 1 dose escalation trial of the selective adenosine A2B antagonist PBF-1129 in patients with metastatic non-small cell lung cancer. Invest New Drugs. 2025 Dec;43(6):1211-1221. doi: 10.1007/s10637-025-01591-y. Epub 2025 Dec 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PBF-1129	Monoclonal antibody	40 mg	Oral
Subject	PBF-1129	Monoclonal antibody	80 mg	Oral
Subject	PBF-1129	Monoclonal antibody	160 mg	Oral
Subject	PBF-1129	Monoclonal antibody	320 mg	Oral

Indications

No indication recorded.