NCT06925321 · Basilea Pharmaceutica
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
What this study is about
The purpose of this study is to evaluate the effectiveness and safety of fosmanogepix (administered IV or taken by mouth) for the treatment of adult patients with invasive mold infections. The study is looking for patients who have been diagnosed with invasive mold infections.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Patient's condition allows for appropriate infection source control measures. Main
Exclusion criteria
- Refractory hematologic malignancy.
- Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
- Coronavirus disease 2019 (COVID-19) associated mucormycosis.
- Invasive fungal disease caused by more than one fungal pathogen is not permitted in Cohort A but is permitted in Cohort B.
- Patients with a Karnofsky Performance Status \< 20 at Screening.
- Requirement, or anticipated requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.
- Patients with known human immunodeficiency virus infection.
- Ongoing neurological disorders.
- Patients receiving hospice/comfort care only.
- Other medical or psychiatric condition.
- Current use of any prohibited concomitant medication(s).
- Current/ previous administration of an investigational drug within 30 days.
- Prior enrollment in this or any previous study of fosmanogepix.
- Moderate or severe hepatic impairment.
- Patient who is pregnant or lactating.
- Known hypersensitivity to fosmanogepix, manogepix, or any of their excipients.
Where
- Birmingham, Alabama
- Duarte, California
- Los Angeles, California
- Sacramento, California
- Chicago, Illinois
- Lexington, Kentucky
- Baltimore, Maryland
- Ann Arbor, Michigan
- Detroit, Michigan
- Minneapolis, Minnesota
- St Louis, Missouri
- New York, New York
And 5 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations