Axatilimab Clinical Trials

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

A Pivotal Trial 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

If you are interested in learning more about enrolling your patients, 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
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
EXPLORE THE MECHANISM OF ACTION HERE.
A Study of Axatilimab at 3 Different Doses in Patients With Chronic Graft Versus Host Disease (cGVHD) (AGAVE-201/NCT04710576)
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
 
CLINICAL TRIAL: ACTIVE, NOT RECRUITING

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

A Phase 1/2 Study to Evaluate axatilimab (SNDX-6352) in Subjects With Active cGVHD
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.

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