Status:
RECRUITING
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
Lead Sponsor:
Basilea Pharmaceutica
Collaborating Sponsors:
Biomedical Advanced Research and Development Authority
Conditions:
Invasive Mold Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of fosmanogepix (administered IV or oral) for the treatment of adult patients with invasive mold infections. The study is looking for p...
Eligibility Criteria
Inclusion
- Main Inclusion Criteria:
- Diagnosis of proven or probable Invasive mold infection (IMI) defined in accordance with the Revision and Update of the Consensus Definitions of Invasive Fungal Disease from the EORTC/MSGERC as adapted for this study and caused by Aspergillus spp. (in patients with limited treatment options), Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multi-drug resistant molds.
- Patient's condition allows for appropriate infection source control measures.
- Main Exclusion Critera:
- Refractory hematologic malignancy.
- Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
- COVID-19 associated mucormycosis.
- Invasive fungal disease caused by more than one fungal pathogen is not permitted in Cohort A but is permitted in Cohort B.
- Patients with a Karnofsky Performance Status \< 20 at Screening.
- Requirement, or anticipated requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.
- Patients with known human immunodeficiency virus infection.
- Ongoing neurological disorders.
- Patients receiving hospice/comfort care only.
- Other medical or psychiatric condition.
- Current use of any prohibited concomitant medication(s).
- Current/ previous administration of an investigational drug within 30 days.
- Prior enrollment in this or any previous study of fosmanogepix.
- Moderate or severe hepatic impairment.
- Patient who is pregnant or lactating.
- Known hypersensitivity to fosmanogepix, manogepix, or any of their excipients.
Exclusion
Key Trial Info
Start Date :
August 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT06925321
Start Date
August 26 2025
End Date
February 1 2028
Last Update
December 22 2025
Active Locations (13)
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1
University of Alabama at Birmingham School of Medicine, Department of Medicine
Birmingham, Alabama, United States, 35294-0006
2
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095-1690
3
Karmanos Cancer Institute - Detroit
Detroit, Michigan, United States, 48201
4
University of Minnesota, M Health Fairview Medical Center
Minneapolis, Minnesota, United States, 55455