A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD

Summary

This is a Phase 1/2, Open-label, Dose Escalation study to investigate axatilimab in participants with active chronic graft versus host disease (cGVHD).

Timeline

Start

2018-11-01

Primary completion

2022-08-12

Completion

2024-10-18

Outcome

Met primary endpoint

paper In phI, a dose of 3 mg/kg given once every 4 weeks met the optimal biologic dose definition. PMID 36459673 ↗

paper With the 50% ORR at cycle 7 day 1, the phII cohort met the primary efficacy end point. PMID 36459673 ↗

Publications

• Kitko CL, Arora M, DeFilipp Z, Zaid MA, Di Stasi A, Radojcic V, Betts CB, Coussens LM, Meyers ML, Qamoos H, Ordentlich P, Kumar V, Quaranto C, Schmitt A, Gu Y, Blazar BR, Wang TP, Salhotra A, Pusic I, Jagasia M, Lee SJ. Axatilimab for Chronic Graft-Versus-Host Disease After Failure of at Least Two Prior Systemic Therapies: Results of a Phase I/II Study. J Clin Oncol. 2023 Apr 1;41(10):1864-1875. doi: 10.1200/JCO.22.00958. Epub 2022 Dec 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Axatilimab	Monoclonal antibody	0.15 mg/kg	Intravenous
Subject	Axatilimab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Axatilimab	Monoclonal antibody	3 mg/kg	Intravenous

Indications