RecruitingPhase 3NCT06925321

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

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

Sponsor

Basilea Pharmaceutica

Enrollment

234 participants

Start Date

Aug 26, 2025

Study Type

INTERVENTIONAL

Conditions

Invasive Mold Infections

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study evaluates a new antifungal drug called fosmanogepix for treating adults with serious invasive mold infections — dangerous fungal infections caused by organisms like Aspergillus, Fusarium, or Mucor that can be life-threatening, especially in people with weakened immune systems. The drug can be given by IV or by mouth, and will be compared against standard antifungal treatments or used as a salvage option for patients whose infections did not respond to previous therapy. Adults with a confirmed or probable invasive mold infection who are not in hospice care and do not have certain serious conditions (such as HIV or severe liver disease) may be eligible. Participation lasts up to about 8 months and involves receiving the study drug and regular assessments to track survival and infection response. This summary was generated by AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFosmanogepix IV infusion

Fosmanogepix will be administered IV

DRUGStandard of care antifungal therapy

Standard of care antifungal therapy will be administered in accordance with their respective product labels and/or standard practice guidelines

DRUGFosmanogepix oral tablet

Fosmanogepix will be administered orally.

Locations(49)

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

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

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

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

Monash Medical Center Clayton

Clayton, Australia

The Alfred Hospital

Melbourne, Australia

Peter MacCallum Cancer Center

Melbourne, Australia

Royal Melbourne Hospital

Parkville, 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

University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology

Leuven, Belgium

UCL Mont-Godinne University Hospitals

Yvoir, Belgium

University of Alberta

Edmonton, Alberta, Canada

Juravinski Hospital - Hamilton Health Sciences

Hamilton, 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

University Medical Center of Johannes Gutenberg University Mainz

Mainz, Rhineland-Palatinate, Germany

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

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

University Hospital Virgen Macarena

Seville, Andalusia, Spain

Hospital del Mar, Department of Infectious Diseases

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

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

View Full Details on ClinicalTrials.gov

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NCT06925321