Open-label Study of APX001 for Treatment of Patients With Invasive Mold Infections Caused by Aspergillus or Rare Molds

Stopped early · Phase 2

Conditions studied: Invasive Fungal Infections

In brief

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).

Key facts

Study ID

NCT04240886

Run by

Basilea Pharmaceutica

People needed

21

Starts

2020-01-04

Expected to finish

2022-05-09

Last updated by the study team

2025-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• City of Hope (City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California, United States
• IP Address : City of Hope Investigational Drug Services (IDS) — Duarte, California, United States
• Duke Department of Pharmacy/Investigational Drug Service (IDS) — Durham, North Carolina, United States
• Duke Medicine Pavilion — Durham, North Carolina, United States
• Duke University Medical Center (Duke South Clinic) — Durham, North Carolina, United States
• Duke University Medical Center(Duke Hospital) — Durham, North Carolina, United States
• Cliniques Universitaires de Bruxelles Hôpital Erasme - Department of Infectious Diseases — Brussels, Belgium
• UZ Leuven - Department of Haematology — Leuven, Belgium
• CHU UCL Namur - Mont- Godinne University Hospital - Intensive Care Unit — Yvoir, Belgium
• Klinikum Neuperlach, Klinik fur Hamatologie und Onkologie — München, Bavaria, Germany
• Universitätsmedizin der Johannes Gutenberg-Universität Mainz III — Mainz, Germany
• Pharmacy — Haifa, Israel
• Rambam Medical Center — Haifa, Israel
• Pharmacy — Ramat Gan, Israel
• Sheba Medical Center, Tel Hashomer — Ramat Gan, Israel

Full record on ClinicalTrials.gov

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