Phase Ib First in Human Dose Escalation of GT103 in Refractory, Advanced Stage Non-Small Cell Lung Cancer (TOP 1902)

Phase 1 Completed 31 enrolled Edward Patz

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this research study is to determine the maximum tolerated dose of GT103 and investigate the safety and effectiveness of the study drug.

Timeline

Start: 2020-06-09
Primary completion: 2024-04-11
Completion: 2024-12-30

Outcome

Met primary endpoint

paper The study achieved its primary objective of demonstrating safety and tolerability of GT103 in refractory NSCLC. PMID 39747856 ↗

Publications

Clarke JM, Simon GR, Mamdani H, Gu L, Herndon JE 2nd, Stinchcombe TE, Ready N, Crawford J, Sonpavde G, Balevic S, Nixon AB, Campa M, Gottlin EB, Li H, Saxena R, He YW, Antonia S, Patz EF Jr. Complement factor H targeting antibody GT103 in refractory non-small cell lung cancer: a phase 1b dose escalation trial. Nat Commun. 2025 Jan 2;16(1):93. doi: 10.1038/s41467-024-55092-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GT103	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	GT103	Monoclonal antibody	1 mg/kg	Intravenous
Subject	GT103	Monoclonal antibody	3 mg/kg	Intravenous
Subject	GT103	Monoclonal antibody	10 mg/kg	Intravenous
Subject	GT103	Monoclonal antibody	15 mg/kg	Intravenous