RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Interventional Phase 3, Open-label, Two-cohort Study to Investigate the Efficacy and Safety of Fosmanogepix in Adult Patients With Invasive Mold Infections Caused by Aspergillus Spp., Fusarium Spp., Lomentospora Prolificans, Mucorales Fungi, or Other Multidrug Resistant Molds

Quick Facts

Study Start:2025-07
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06925321

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Patient's condition allows for appropriate infection source control measures.
  3. 1. Refractory hematologic malignancy.
  4. 2. Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
  5. 3. COVID-19 associated mucormycosis.
  6. 4. Invasive fungal disease caused by more than one fungal pathogen is not permitted in Cohort A but is permitted in Cohort B.
  7. 5. Patients with a Karnofsky Performance Status \< 20 at Screening.
  8. 6. Requirement, or anticipated requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.
  9. 7. Patients with known human immunodeficiency virus infection.
  10. 8. Ongoing neurological disorders.
  11. 9. Patients receiving hospice/comfort care only.
  12. 10. Other medical or psychiatric condition.
  13. 11. Current use of any prohibited concomitant medication(s).
  14. 12. Current/ previous administration of an investigational drug within 30 days.
  15. 13. Prior enrollment in this or any previous study of fosmanogepix.
  16. 14. Moderate or severe hepatic impairment.
  17. 15. Patient who is pregnant or lactating.
  18. 16. Known hypersensitivity to fosmanogepix, manogepix, or any of their excipients.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Daniel Ionescu, MD
CONTACT
+41763192318
Daniel.Ionescu@basilea.com
Marc Engelhardt, MD
CONTACT
+41797010551
marc.engelhardt@basilea.com

Principal Investigator

Daniel Ionescu, MD
STUDY_DIRECTOR
Basilea Pharmaceutica International Ltd, Allschwil

Study Locations (Sites)

Washington University School of Medicine, Infectious Diseases Clinical Research Unit
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Basilea Pharmaceutica

  • Daniel Ionescu, MD, STUDY_DIRECTOR, Basilea Pharmaceutica International Ltd, Allschwil

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07
Study Completion Date2028-02

Study Record Updates

Study Start Date2025-07
Study Completion Date2028-02

Terms related to this study

Keywords Provided by Researchers

  • Fungal infection
  • Antifungal
  • Mold infection
  • Rare molds
  • Multidrug resistant mold
  • Aspergillus spp.
  • Fusarium spp.
  • Lomentospora prolificans
  • Mucorales fungi
  • Scedosporium spp.

Additional Relevant MeSH Terms

  • Invasive Mold Infections