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RecruitingPhase 3

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

Basilea Pharmaceutica · with Biomedical Advanced Research and Development Authority · NCT06925321

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
234
US sites recruiting
19
Study start
August 26, 2025
Record last updated
September 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Fosmanogepix IV infusion; Standard of care antifungal therapy; Fosmanogepix oral tablet

Conditions: Invasive Mold Infections

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Main 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 Critera

  • 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.

Recruiting US locations

  • University of Alabama at Birmingham School of Medicine, Department of Medicine

    Birmingham, AL 35294-0006

  • City of Hope

    Duarte, CA 91010

  • David Geffen School of Medicine at UCLA

    Los Angeles, CA 90095-1690

  • UC Davis Medical Center

    Sacramento, CA 95817

  • Memorial Healthcare System

    Hollywood, FL 33021

  • Rush University Medical Center, Division of Infectious Diseases

    Chicago, IL 60612

  • University of Kentucky Medical Center, Division of Infectious Diseases

    Lexington, KY 40506

  • Johns Hopkins Hospital

    Baltimore, MD 21231

  • University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center

    Ann Arbor, MI 48109-5000

  • University of Minnesota, M Health Fairview Medical Center

    Minneapolis, MN 55455

  • Washington University School of Medicine, Infectious Diseases Clinical Research Unit

    St Louis, MO 63110

  • Weill Cornell Medical College - NewYork-Presbyterian Hospital

    New York, NY 10021

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    New York, NY 10065

  • University of North Carolina at Chapel Hill

    Chapel Hill, NC 27514

  • Duke University Medical Center, Duke Infectious Diseases

    Durham, NC 27710

  • University of Pennsylvania School of Medicine

    Philadelphia, PA 19104-6243

  • The University of Texas Health Science Center at Houston, Department of Internal Medicine

    Houston, TX 77030

  • UT MD Anderson Cancer Center

    Houston, TX 77030

  • University of Texas Health Science Center at San Antonio

    San Antonio, TX 78229

Study contacts (from the official record)

  • Alison Kuchta, MD · +41616061243 · kuchtaa@basileapharma.com
  • Marc Engelhardt, MD · +41797010551 · marc.engelhardt@basilea.com
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the… (NCT06925321) | Bored Studies