Axatilimab Clinical Trials

 

CLINICAL TRIAL NOW RECRUITING: Patients with recurrent or refractory active chronic graft-versus-host disease (cGVHD)

AGAVE-201/NCT04710576, a Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients With Recurrent or Refractory Active Chronic Graft Versus Host Disease Who Have Received at Least 2 Lines of Systemic Therapy1,2

Intervention: Axatilimab (SNDX-6352) IV infusion. Enroll: If you are interested in learning more about enrolling your patients in AGAVE-201, contact us directly at clinicaltrials@syndax.com
Intervention: Axatilimab (SNDX-6352) IV infusion. Enroll: If you are interested in learning more about enrolling your patients in AGAVE-201, contact us directly at clinicaltrials@syndax.com

Axatilimab (SNDX-6352) is a high affinity antibody targeting the colony stimulating factor 1 receptor (CSF-1R). CSF-1R signaling has been demonstrated in nonclinical studies to be a key regulatory pathway involved in the expansion and infiltration of donor-derived macrophages that mediate the disease processes involved in cGVHD.1
NCT04710576 is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab, a CSF-1R inhibitor, at 3 different dose levels in patients with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received at least 2 prior lines of systemic therapy due to progression of disease, intolerability or toxicity.1
This trial is actively recruiting.1
For full trial information, see this trial on ClinicalTrials.gov

If you are interested in learning more about enrolling your patients, contact us directly at clinicaltrials@syndax.com.

 


CLINICAL TRIAL: Patients with active chronic graft versus host disease (cGVHD)

Clinical trial SNDX-6352-503/NCT03604692, a Phase 1/2 dose escalation study investigating axatilimab (SNDX-6352), a CSF-1R (colony-stimulating factor 1 receptor) inhibitor in patients with active cGVHD2,3

Axatilimab (SNDX-6352) is a high affinity antibody targeting the colony stimulating factor 1 receptor (CSF-1R). CSF-1R signaling has been demonstrated in nonclinical studies to be a key regulatory pathway involved in the expansion and infiltration of donor-derived macrophages that mediate the disease processes involved in cGVHD.3
NCT03604692 is a Phase 1/2, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic activity, and efficacy of axatilimab (SNDX-6352) in subjects with chronic graft versus host disease who have received at least 2 lines of prior therapy.3
For full trial information, see this trial on ClinicalTrials.gov

 
References:

  1. A Study of Axatilimab at 3 Different Doses in Patients With Chronic Graft Versus Host Disease (cGVHD) (AGAVE-201). ClinicalTrials.gov Identifier: NCT04710576.https://clinicaltrials.gov/ct2/show/NCT04710576. Accessed January 20, 2021.
  2. Data on file. Syndax Pharmaceuticals, Inc.
  3. A phase 1 study to evaluate SNDX-6352 in subjects with active cGVHD. ClinicalTrials.gov identifier: NCT03604692. https://clinicaltrials.gov/ct2/show/NCT03604692. Updated August 6, 2019. Accessed May 6, 2020.