A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
Recruiting now · Phase 3
Conditions studied: Invasive Mold Infections
In brief
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 patients who have been diagnosed with invasive mold infections. The maximum study duration will be approximately 8 months, including a target study treatment duration of 84 days which can be extended up to 180 days and follow-up period. 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.
Key facts
- Study ID
- NCT06925321
- Run by
- Basilea Pharmaceutica
- People needed
- 234
- Starts
- 2025-08-26
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-07-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope — Duarte, California, United States (enrolling)
- David Geffen School of Medicine at UCLA — Los Angeles, California, United States (enrolling)
- UC Davis Medical Center — Sacramento, California, United States (enrolling)
- Memorial Healthcare System — Hollywood, Florida, United States (enrolling)
- Rush University Medical Center, Division of Infectious Diseases — Chicago, Illinois, United States (enrolling)
- University of Kentucky Medical Center, Division of Infectious Diseases — Lexington, Kentucky, United States (enrolling)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
- University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center — Ann Arbor, Michigan, United States (enrolling)
- Karmanos Cancer Institute - Detroit — Detroit, Michigan, United States (enrolling)
- University of Minnesota, M Health Fairview Medical Center — Minneapolis, Minnesota, United States (enrolling)
- Washington University School of Medicine, Infectious Diseases Clinical Research Unit — St Louis, Missouri, United States (enrolling)
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
- Duke University Medical Center, Duke Infectious Diseases — Durham, North Carolina, United States (enrolling)
- University of Pennsylvania School of Medicine — Philadelphia, Pennsylvania, United States (enrolling)
- The University of Texas Health Science Center at Houston, Department of Internal Medicine — Houston, Texas, United States (enrolling)
- UT MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (enrolling)
- Monash Medical Center Clayton — Clayton, Australia (enrolling)
- The Alfred Hospital — Melbourne, Australia (enrolling)
- Peter MacCallum Cancer Center — Melbourne, Australia (enrolling)
- Royal Melbourne Hospital — Parkville, Australia (enrolling)
- Westmead Hospital — Westmead, Australia (enrolling)
- Princess Alexandra Hospital — Woolloongabba, Australia (enrolling)
- University of Alabama at Birmingham School of Medicine, Department of Medicine — Birmingham, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
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