APX001-202
To evaluate the safety and efficacy of APX001 for the treatment of adult patients aged 18 years and above with IMIs caused by Aspergillus spp. or rare molds, who have limited antifungal treatment options.
Study treatments
APX001 IV or oral for up to 42 days
Inclusion criteria
- 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
- Limited or no treatment options due to documented or anticipated resistance, contra-indication, intolerance, or lack of clinical response to SOC antifungal therapy, as advocated by the relevant regional treatment guidelines
Exclusion criteria
- Refractory hematologic malignancy
- Chronic aspergillosis, aspergilloma or allergic bronchopulmonary aspergillosis
- Treatment with systemic mold active antifungal therapy for ≥ 120 hours immediately before initial dosing
- Evidence of significant hepatic dysfunction, defined as any of the following: total bilirubin ≥ 3x ULN, ALT/AST ≥5x ULN, severe or moderate hepatic impairment at any time during 2 weeks prior to dosing
Participating sites
- University Hospital Leuven Gasthuisberg