Fosmanogepix treatment for adults with invasive mold infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with proven or probable invasive mold infections (including Aspergillus with limited options, Fusarium, Lomentospora prolificans, Mucorales, or other multidrug-resistant molds) are enrolled and assigned to one of two cohorts. Cohort A (primary therapy) receives either fosmanogepix or the site’s standard antifungal regimen, while Cohort B (salvage therapy) receives fosmanogepix after prior treatment failure or intolerance. Fosmanogepix is given intravenously or orally for a target of 84 days (which can be extended to 180 days) within a total study duration of about 8 months including follow-up. The primary outcome compares all-cause mortality at Day 42 against a fixed threshold to determine efficacy and safety.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham School of Medicine, Department of Medicine
  Birmingham, Alabama, United States Recruiting
• City of Hope
  Duarte, California, United States Recruiting
• David Geffen School of Medicine at UCLA
  Los Angeles, California, United States Recruiting
• UC Davis Medical Center
  Sacramento, California, United States Recruiting
• Memorial Healthcare System
  Hollywood, Florida, United States Recruiting
• Rush University Medical Center, Division of Infectious Diseases
  Chicago, Illinois, United States Recruiting

+40 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Alison Kuchta, MD
• Email: kuchtaa@basileapharma.com
• Phone: +41616061243

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Immune monitoring during invasive mold infections.

  This project will test whether tracking T-cell immune checkpoints can identify adults with invasive mold infections who might benefit from adding immunotherapy to antifungal treatment.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT06285188

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.