A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
NCT ID: NCT06925321
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
219 participants
INTERVENTIONAL
2025-08-26
2028-02-29
Brief Summary
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The patient will be assigned to one of two treatment cohorts:
Cohort A (primary therapy): Patients will receive either the study drug or institutional standard of care antifungal treatment.
Cohort B (salvage treatment; i.e. treatment given after patients did not respond to previous treatments or did not tolerate them): Patients will receive the study drug
The primary aim is to compare the all cause mortality with a fixed threshold at Day 42.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A: Experimental Treatment
Patients will receive the study drug.
Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.
Fosmanogepix IV infusion
Fosmanogepix will be administered IV
Fosmanogepix oral tablet
Fosmanogepix will be administered orally.
Cohort A: Comparator Antifungal Treatment
Best available therapy (BAT) administered as IV or orally per standard guidelines.
Standard of care antifungal therapy
Standard of care antifungal therapy will be administered in accordance with their respective product labels and/or standard practice guidelines
Cohort B
Patients will receive the study drug.
Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.
Fosmanogepix IV infusion
Fosmanogepix will be administered IV
Fosmanogepix oral tablet
Fosmanogepix will be administered orally.
Interventions
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Fosmanogepix IV infusion
Fosmanogepix will be administered IV
Standard of care antifungal therapy
Standard of care antifungal therapy will be administered in accordance with their respective product labels and/or standard practice guidelines
Fosmanogepix oral tablet
Fosmanogepix will be administered orally.
Eligibility Criteria
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Inclusion Criteria
2. Patient's condition allows for appropriate infection source control measures.
Main Exclusion Critera:
1. Refractory hematologic malignancy.
2. Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
3. COVID-19 associated mucormycosis.
4. Invasive fungal disease caused by more than one fungal pathogen is not permitted in Cohort A but is permitted in Cohort B.
5. Patients with a Karnofsky Performance Status \< 20 at Screening.
6. Requirement, or anticipated requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.
7. Patients with known human immunodeficiency virus infection.
8. Ongoing neurological disorders.
9. Patients receiving hospice/comfort care only.
10. Other medical or psychiatric condition.
11. Current use of any prohibited concomitant medication(s).
12. Current/ previous administration of an investigational drug within 30 days.
13. Prior enrollment in this or any previous study of fosmanogepix.
14. Moderate or severe hepatic impairment.
15. Patient who is pregnant or lactating.
16. Known hypersensitivity to fosmanogepix, manogepix, or any of their excipients.
18 Years
ALL
No
Sponsors
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Biomedical Advanced Research and Development Authority
FED
Basilea Pharmaceutica
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Ionescu, MD
Role: STUDY_DIRECTOR
Basilea Pharmaceutica International Ltd, Allschwil
Locations
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University of Alabama at Birmingham School of Medicine, Department of Medicine
Birmingham, Alabama, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Karmanos Cancer Institute - Detroit
Detroit, Michigan, United States
University of Minnesota, M Health Fairview Medical Center
Minneapolis, Minnesota, United States
Washington University School of Medicine, Infectious Diseases Clinical Research Unit
St Louis, Missouri, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center, Duke Infectious Diseases
Durham, North Carolina, United States
Princess Alexandra Hospital
Woolloongabba, , Australia
Chaim Sheba Medical Center, Department of Infectious Diseases
Ramat Gan, , Israel
The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit
Tel Aviv, , Israel
Faculty of Medicine, Siriraj Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Songklanagarind Hospital
Hat Yai, , Thailand
Countries
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Central Contacts
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Other Identifiers
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FMGX-CS-302
Identifier Type: -
Identifier Source: org_study_id