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New hope against deadly molds? early trial cut short

NCT ID NCT04240886

Disease control Sponsor: Basilea Pharmaceutica Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a drug called fosmanogepix in 21 adults with invasive mold infections (like Aspergillus or rare molds) who had few other options. The trial was stopped early, so we have limited data on how well it works or its safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fosmanogepix (also called APX001)
What this could lead to
If successful, this could provide a new treatment option for people with hard-to-treat invasive mold infections who cannot use standard therapies.
What could go wrong
This was a small, early-phase trial that was terminated, so results are limited. The drug may not prove effective or safe in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

21 people

The number who actually took part.

Started

Jan 2020

Finished

May 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males or females, 18 years or older. * Patients with proven or probable IMI caused by Aspergillus spp. Patients who present with IMI due to other filamentous fungi (eg, Scedosporium spp., Fusarium spp., and Mucorales fungi such as Mucor spp. or Rhizopus spp.) may also be enrolled. * Have limited or no treatment options due to documented or anticipated resistance, contraindication, intolerance, or lack of clinical response to SOC antifungal therapy, as advocated by the relevant regional/country treatment guidelines. * Patients where the Investigator considers that there is a potential advantage of using APX001 over current SOC (eg, broad spectrum of activity, emergence of IMI during antifungal prophylaxis, activity against resistant mold pathogens, IV and PO formulations, favorable DDI profile, favorable hepatic and renal safety profile, wide tissue distribution including brain), and/or where the SOC antifungal therapy carries significant risk of toxicity or treatment failure (eg, DDI risk, safety/toxicity risk, site of infection not accessible by SOC). Exclusion Criteria: * Refractory hematologic malignancy. * Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis. * Treatment with systemic (PO, IV, or inhaled) mold active antifungal therapy for 120 hours immediately before initial dosing. Note: patients with invasive fungal infection caused by a mold with documented resistance to or lack of coverage by the prior SOC in question, may have received \>120 hours prior treatment and remain eligible for the study. * Evidence of significant hepatic dysfunction.

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Conditions

The condition(s) this trial relates to.

aspergillosis COVID-19 fungal infectious disease fusariosis invasive aspergillosis Invasive Fungal Infections pulmonary aspergilloma scedosporiosis systemic mycosis Zygomycosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Invasive fungal infections

Contacts and locations

Locations

  • CHU UCL Namur - Mont- Godinne University Hospital - Intensive Care Unit

    Yvoir, 5530, Belgium

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    Duarte, California, 91010, United States

  • Cliniques Universitaires de Bruxelles Hôpital Erasme - Department of Infectious Diseases

    Brussels, 1070, Belgium

  • Duke Department of Pharmacy/Investigational Drug Service (IDS)

    Durham, North Carolina, 27710, United States

  • Duke Medicine Pavilion

    Durham, North Carolina, 27710, United States

  • Duke University Medical Center (Duke South Clinic)

    Durham, North Carolina, 27710, United States

  • Duke University Medical Center(Duke Hospital)

    Durham, North Carolina, 27710, United States

  • IP Address : City of Hope Investigational Drug Services (IDS)

    Duarte, California, 91010, United States

  • Klinikum Neuperlach, Klinik fur Hamatologie und Onkologie

    München, Bavaria, 81737, Germany

  • Pharmacy

    Haifa, 3109601, Israel

  • Pharmacy

    Ramat Gan, 5262160, Israel

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Sheba Medical Center, Tel Hashomer

    Ramat Gan, 5262160, Israel

  • UZ Leuven - Department of Haematology

    Leuven, 3000, Belgium

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz III

    Mainz, 55131, Germany

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