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A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.

RecruitingPhase 3Ages 18 Years - anyAllBasilea Pharmaceutica
NCT06925321 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Main Inclusion Criteria: 1. 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. 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. Coronavirus disease 2019 (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.
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What it tests

  • Fosmanogepix IV infusion
  • Standard of care antifungal therapy
  • Fosmanogepix oral tablet
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Where

84 sites
University of Alabama at Birmingham School of Medicine, Department of Medicine
Birmingham, United States
City of Hope
Duarte, United States
David Geffen School of Medicine at UCLA
Los Angeles, United States
UC Davis Medical Center
Sacramento, United States
Memorial Healthcare System
Hollywood, United States
Rush University Medical Center, Division of Infectious Diseases
Chicago, United States
University of Kentucky Medical Center, Division of Infectious Diseases
Lexington, United States
Johns Hopkins Hospital
Baltimore, United States

…and 76 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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