A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)

Active:	No
Cancer Type:	Unknown Primary	NCT ID:	NCT04710576
Trial Phases:	Phase II	Protocol IDs:	SNDX-6352-0504 (primary) NCI-2021-01333
Eligibility:	2 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Syndax Pharmaceuticals
NCI Full Details:	http://clinicaltrials.gov/show/NCT04710576

Summary

This is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab
at 3 different dose levels in participants with recurrent or refractory active chronic
graft versus host disease (cGVHD) who have received at least 2 prior lines of systemic
therapy.

Objectives

AGAVE-201 is a Phase 2, open-label, randomized, multicenter study to evaluate the
efficacy, safety, and tolerability of axatilimab in participants with recurrent or
refractory active cGVHD after failure of at least 2 prior lines of systemic therapy due
to progression of disease, intolerability, or toxicity.

Participants will be randomized to receive 1 of 3 different axatilimab treatment regimens
in 28-day treatment cycles for up to 2 years.

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