Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

This is a Phase 2, multicenter study to evaluate APX001 for the treatment of invasive fungal infections caused by Aspergillus spp. or rare molds (eg, Scedosporium spp., Fusarium spp., and Mucorales fungi).

Official Title

A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of APX001 in the Treatment of Patients With Invasive Mold Infections Caused by Aspergillus Species or Rare Molds

Keywords

Invasive Fungal Infections APX001 APX001A fosmanogepix manogepix aspergillus aspergillosis covid covid19 mold mould pulmonary aspergillosis pulmonary aspergillus galactomannan Karius SARS-CoV-2 fusarium mucorales mucor rhizopus scedosporium fungal disease invasive fungal disease EORTC Infections Communicable Diseases Mycoses

Eligibility

You can join if…

Open to people ages 18 years and up

  • Males or females, 18 years or older.
  • Patients with proven or probable IMI caused by Aspergillus spp. Patients who present with IMI due to other filamentous fungi (eg, Scedosporium spp., Fusarium spp., and Mucorales fungi such as Mucor spp. or Rhizopus spp.) may also be enrolled.
  • Have limited or no treatment options due to documented or anticipated resistance, contraindication, intolerance, or lack of clinical response to SOC antifungal therapy, as advocated by the relevant regional/country treatment guidelines.
  • Patients where the Investigator considers that there is a potential advantage of using APX001 over current SOC (eg, broad spectrum of activity, emergence of IMI during antifungal prophylaxis, activity against resistant mold pathogens, IV and PO formulations, favorable DDI profile, favorable hepatic and renal safety profile, wide tissue distribution including brain), and/or where the SOC antifungal therapy carries significant risk of toxicity or treatment failure (eg, DDI risk, safety/toxicity risk, site of infection not accessible by SOC).

You CAN'T join if...

  • Refractory hematologic malignancy.
  • Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
  • Treatment with systemic (PO, IV, or inhaled) mold active antifungal therapy for 120 hours immediately before initial dosing. Note: patients with invasive fungal infection caused by a mold with documented resistance to or lack of coverage by the prior SOC in question, may have received >120 hours prior treatment and remain eligible for the study.
  • Evidence of significant hepatic dysfunction.

Locations

  • Clinical Trial Site accepting new patients
    Sacramento California 95616 United States
  • Clinical Trial Site accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amplyx Pharmaceuticals
Links
Sign up for this study
ID
NCT04240886
Phase
Phase 2
Study Type
Interventional
Last Updated