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A Phase 1, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of SNDX-6352 in Subjects With Active Chronic Graft Versus Host Disease Who Have Received at Least 2 Lines of Prior Therapy

Trial Profile

A Phase 1, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of SNDX-6352 in Subjects With Active Chronic Graft Versus Host Disease Who Have Received at Least 2 Lines of Prior Therapy

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 10 Jan 2020

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At a glance

  • Drugs UCB 6352 (Primary)
  • Indications Graft-versus-host disease
  • Focus Adverse reactions
  • Sponsors Syndax Pharmaceuticals
  • Most Recent Events

    • 10 Jan 2020 According to a Syndax Pharmaceuticals media release, The Company has also initiated a Phase 2 expansion cohort for SNDX-6352. The Phase 2 expansion cohort is expected to enroll up to 22 patients to further characterize the safety and efficacy at an initial dosing schedule of 1.0 mg/kg of SNDX-6352 administered every two weeks. The Company expects to present results from the Phase 1 trial, for which dose escalation remains ongoing, in the second half of 2020.
    • 10 Dec 2019 According to a Syndax Pharmaceuticals media release, company has decided to advance into a Phase 2 expansion cohort to evaluate additional patients at the 1.0 mg/kg dose while continue the dose escalation to 3.0 mg/kg in cohort 4.
    • 10 Dec 2019 Interim results ( November 25, 2019 data cutoff date, n=5)) presented in a Syndax Pharmaceuticals Media Release.
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