Comparing 3 approaches for invasive mold infections
Official title: 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
- Phase 3
- 3 groups
- Sites in Vancouver, Edmonton and 2 more cities
- Recruiting
Interventions
- Medication
Fosmanogepix IV infusion
Fosmanogepix will be administered IV
- Medication
Standard of care antifungal therapy
Standard of care antifungal therapy will be administered in accordance with their respective product labels and/or standard practice guidelines
- Medication
Fosmanogepix oral tablet
Fosmanogepix will be administered orally.
Canadian Sites (4)
4 of 4 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta
- Recruiting
Juravinski Hospital - Hamilton Health Sciences
Hamilton, Ontario
- Recruiting
Ottawa Hospital
Ottawa, Ontario
- Recruiting
Vancouver Coastal Health Research Institute (VCHRI)
Vancouver
Eligibility Criteria
See who this study is looking for19 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
- +Known hypersensitivity to fosmanogepix, manogepix, or any of their excipients.
- +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 controlControl groupThe group a new treatment is measured against.Read more → measures.
- +Main ExclusionExclusion criteriaThe things that would prevent someone from taking part.Read more → Critera:
- +Refractory hematologic malignancy.
- +Coronavirus disease 2019 (COVID-19) associated mucormycosis.
- +Invasive fungal disease caused by more than one fungal pathogen is not permitted in CohortCohortA group of participants sharing a characteristic, followed together.Read more → A but is permitted in Cohort B.
- +Patients with a Karnofsky Performance Status \< 20 at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in this or any previous study of fosmanogepix.
- +Moderate or severe hepatic impairment.
- +Patient who is pregnant or lactating.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Groups A and C receive one or more of: Fosmanogepix IV infusion and Fosmanogepix oral tablet.
Registry label: A: Cohort A: Experimental Treatment · C: Cohort B
Group B, the comparison group, receives Standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → antifungal therapy.
Registry label: B: Cohort A: Comparator Antifungal Treatment
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 234 people.
The study is currently expected to finish around February 2028.
The main measurement is taken over: Day 42.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Day 42 all-cause mortality rate — measured over Day 42.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06925321 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Fosmanogepix IV infusionDrug
Fosmanogepix will be administered IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Standard of care antifungal therapyDrug
Standard of care antifungal therapy will be administered in accordance with their respective product labels and/or standard practice guidelines
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Fosmanogepix oral tabletDrug
Fosmanogepix will be administered orally.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Day 42.
The study as a whole is currently expected to finish around 2028-02.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 234 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 8 locations, including: Vancouver, Canada; Edmonton, Alberta, Canada; Hamilton, Ontario, Canada; Ottawa, Ontario, Canada; Ann Arbor, Michigan, United States; Detroit, Michigan, United States, and 2 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (5)
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
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
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.