RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Basilea Pharmaceutica • ClinicalTrials.gov ID: NCT06925321

Registry updated: 2026-09-14

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

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.

Interventions

Fosmanogepix IV infusion (Drug)
Fosmanogepix will be administered IV
Standard of care antifungal therapy (Drug)
Standard of care antifungal therapy will be administered in accordance with their respective product labels and/or standard practice guidelines
Fosmanogepix oral tablet (Drug)
Fosmanogepix will be administered orally.

Eligibility criteria

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.

Conditions

Invasive Mold Infections

Locations

University of Alabama at Birmingham School of Medicine, Department of Medicine — Birmingham, Alabama, United States
City of Hope — Duarte, California, United States
David Geffen School of Medicine at UCLA — Los Angeles, California, United States
UC Davis Medical Center — Sacramento, California, United States
Memorial Healthcare System — Hollywood, Florida, United States
Rush University Medical Center, Division of Infectious Diseases — Chicago, Illinois, United States
University of Kentucky Medical Center, Division of Infectious Diseases — Lexington, Kentucky, United States
Johns Hopkins Hospital — Baltimore, Maryland, United States
University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center — Ann Arbor, Michigan, United States
Karmanos Cancer Institute - Detroit — Detroit, Michigan, United States
University of Minnesota, M Health Fairview Medical Center — Minneapolis, Minnesota, United States
Washington University School of Medicine, Infectious Diseases Clinical Research Unit — St Louis, Missouri, United States
Weill Cornell Medical College - NewYork-Presbyterian Hospital — New York, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York, United States
University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
Duke University Medical Center, Duke Infectious Diseases — Durham, North Carolina, United States
University of Pennsylvania School of Medicine — Philadelphia, Pennsylvania, United States
The University of Texas Health Science Center at Houston, Department of Internal Medicine — Houston, Texas, United States
UT MD Anderson Cancer Center — Houston, Texas, United States
University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
Monash Medical Center Clayton — Clayton, Australia
The Alfred Hospital — Melbourne, Australia
Peter MacCallum Cancer Center — Melbourne, Australia
Royal Melbourne Hospital — Parkville, Australia
Westmead Hospital — Westmead, Australia
Princess Alexandra Hospital — Woolloongabba, Australia
Kepler University Hospital GmbH, Department of Internal Medicine IV - Pulmonology — Linz, Austria
Medical University Vienna, Department of Internal Medicine I, Clinical Department of Infections and Tropical Medicine — Vienna, Austria
Charleroi Grand Hospital (GHDC) - Les Viviers Site — Charleroi, Belgium
Jessa Hospital — Hasselt, Belgium
University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology — Leuven, Belgium
UCL Mont-Godinne University Hospitals — Yvoir, Belgium
HC-UFPR — Curitiba, Paraná, Brazil
Hospital Our Lady of Grace — Curitiba, Paraná, Brazil
Paulista School of Medicine at Federal University of Sao Paulo, UNIFESP — São Paulo, São Paulo, Brazil
Porto Alegre Clinical Hospital (HCPA) — Porto Alegre, Brazil
Hospital A.C.Camargo ("Antonio Prudente" Foundation) — São Paulo, Brazil
"Santa Marcelina" Hospital — São Paulo, Brazil
University of Alberta — Edmonton, Alberta, Canada
Juravinski Hospital - Hamilton Health Sciences — Hamilton, Ontario, Canada
Ottawa Hospital — Ottawa, Ontario, Canada
Vancouver Coastal Health Research Institute (VCHRI) — Vancouver, Canada
Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases — Nantes, France
Necker Children's Hospital, Department of Infectious and Tropical Diseases — Paris, France
Rennes University Hospital Center - Pontchaillou Site — Rennes, France
University Hospital Ulm, Comprehensive Infectious Diseases Center Ulm (CIDCU) — Ulm, Baden-Wurttemberg, Germany
University Hospital Cologne, Internal Medicine I - Oncology, Hematology, Clinical Infectiology, Clinical Immunology, Hemostaseology, Internal Intensive Care Medicine, Clinical Study Centre II for Infectious Diseases — Cologne, North Rhine-Westphalia, Germany
University Medical Center of Johannes Gutenberg University Mainz — Mainz, Rhineland-Palatinate, Germany
Frankfurt University Clinic — Frankfurt, Germany
"LAIKO" General Hospital — Athens, Greece
General Hospital of Athens "Evangelismos" — Athens, Greece
University General Hospital "Attikon", 2nd Department of Internal Medicine, Propaedeutic, Hematology Unit — Athens, Greece
General Hospital of Thessaloniki "Ippokratio" — Thessaloniki, Greece
Rambam Health Care Campus, Institute of Infectious Diseases — Haifa, Israel
Chaim Sheba Medical Center, Department of Infectious Diseases — Ramat Gan, Israel
The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit — Tel Aviv, Israel
Shamir Medical Center, Department of Infectious Diseases — Ẕerifin, Israel
IRCCS Policlinic Hospital San Martino — Genova, Italy
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda — Milan, Italy
University Polyclinic Hospital of Modena — Modena, Italy
Polyclinic San Matteo, IRCCS — Pavia, Italy
University Hospital of Pisa — Pisa, Italy
Giuliano Isontina University Health Authority — Trieste, Italy
Radboud University Medical Center (Radboudumc), Department of Intensive Care — Nijmegen, Netherlands
Erasmus Medical Center, Deoartment of Infectious Diseases — Rotterdam, Netherlands
UMC Utrecht, Department of Rheumatology & Clinical Immunology — Utrecht, Netherlands
University Hospital Virgen Macarena — Seville, Andalusia, Spain
Hospital del Mar, Department of Infectious Diseases — Barcelona, Catalonia, Spain
Hospital de la Santa Creu i Sant Pau — Barcelona, Catalonia, Spain
University Hospital Cruces — Barakaldo, Spain
Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
University Hospital Ramon y Cajal, Department of Infectious Diseases — Madrid, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan
China Medical University Hospital — Taichung, Taiwan
Taichung Veterans General Hospital — Taichung, Taiwan
National Taiwan University Hospital — Taipei, Taiwan
Taipei Medical University Hospital — Taipei, Taiwan
Taipei Veterans General Hospital — Taipei, Taiwan
Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan
Faculty of Medicine, Siriraj Hospital — Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital — Chiang Mai, Thailand
Songklanagarind Hospital — Hat Yai, Thailand
Srinagarind Hospital — Khon Kaen, Thailand

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment