Open-label Study of APX001 for Treatment of Patients With Invasive Mold Infections Caused by Aspergillus or Rare Molds
NCT ID: NCT04240886
Last Updated: 2025-09-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
21 participants
INTERVENTIONAL
2020-01-04
2022-05-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A: fosmanogepix (APX001)
fosmanogepix
IV and oral fosmanogepix
Cohort B: fosmanogepix (APX001)
fosmanogepix
IV and oral fosmanogepix
Interventions
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fosmanogepix
IV and oral fosmanogepix
Other Intervention Names
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Eligibility Criteria
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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.
* 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).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Basilea Pharmaceutica
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Engelhardt
Role: STUDY_DIRECTOR
Basilea Pharmaceutica International Ltd, Allschwil
Locations
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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
Countries
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References
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Hodges MR, Tawadrous M, Cornely OA, Thompson GR 3rd, Slavin MA, Maertens JA, Dadwal SS, Rahav G, Hazel S, Almas M, Jakate A, Pypstra R. Fosmanogepix for the Treatment of Invasive Mold Diseases Caused by Aspergillus Species and Rare Molds: A Phase 2, Open-Label Study (AEGIS). Clin Infect Dis. 2025 Apr 9:ciaf185. doi: 10.1093/cid/ciaf185. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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C4791010
Identifier Type: OTHER
Identifier Source: secondary_id
2019-001386-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
APX001-202
Identifier Type: -
Identifier Source: org_study_id
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