A Study of INCAGN01876 in Participants With Advanced or Metastatic Solid Tumors

Phase 1/2 Completed 100 enrolled Incyte Corporation

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This was an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in participants with advanced or metastatic solid tumors that was conducted in 2 parts. Part 1 is dose escalation and safety expansion which determines the optimal dose and maximum number of tolerated doses. Part 2 is dose expansion in which Part 1 recommended dose will be evaluated.

Timeline

Start: 2016-06-20
Primary completion: 2019-12-16
Completion: 2019-12-16

Publications

Hamid O, Cardin DB, Hodi FS, LoRusso P, Merghoub T, Zappasodi R, Maniyar R, Janik JE, van der Velden MVW, Zhou F, Dong Z, Chen X, Harding JJ. First-in-Human Phase I/II Study of INCAGN01876, a Glucocorticoid-Induced Tumor Necrosis Factor Receptor Agonist, in Patients with Advanced or Metastatic Solid Tumors. Clin Cancer Res. 2025 Oct 1;31(19):4089-4100. doi: 10.1158/1078-0432.CCR-24-4141.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RAGIFILIMAB	Monoclonal antibody	0.03 mg/kg	Intravenous
Subject	RAGIFILIMAB	Monoclonal antibody	0.1 mg/kg	Intravenous
Subject	RAGIFILIMAB	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	RAGIFILIMAB	Monoclonal antibody	1 mg/kg	Intravenous
Subject	RAGIFILIMAB	Monoclonal antibody	3 mg/kg	Intravenous
Subject	RAGIFILIMAB	Monoclonal antibody	5 mg/kg	Intravenous
Subject	RAGIFILIMAB	Monoclonal antibody	10 mg/kg	Intravenous
Subject	RAGIFILIMAB	Monoclonal antibody	20 mg/kg	Intravenous
Subject	RAGIFILIMAB	Monoclonal antibody	300 mg/kg	Intravenous
Subject	RAGIFILIMAB	Monoclonal antibody	400 mg/kg	Intravenous

A Study of INCAGN01876 in Participants With Advanced or Metastatic Solid Tumors

Summary

Timeline

Publications

Drugs

Indications