Clinical Trials List
Protocol NumberFMGX-CS-302
Active
2025-07-31 - 2028-09-01
Phase III
Recruiting8
ICD-10B35.0
Tinea barbae and tinea capitis
ICD-9110.0
Dermatophytosis of scalp and beard
A phase 3, open-label, two-group interventional trial investigating the efficacy and safety of fosmanogepix in adult patients with invasive fungal infections caused by Aspergillus, Fusarium, Lomentospora prolificans, Mucorales fungi, or other multidrug-resistant fungi.
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Trial Applicant
TAIWAN PSI HEALTH DEVELOPMENT COMPANY LIMITED
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Sponsor
Taiwan PSI Health Development Company LTD.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/23
Investigators and Locations
Co-Principal Investigator
- Chun-Yu Lin 無
- jong rung Tsai 無
- Tun-Chieh Chen 無
- Chau-Chyun Sheu 無
- Chung-Hao Huang 無
- Shih-Feng Cho 無
- Wei-An Chang 無
- Ming-Ju Tsai 無
- Shang-Yi Lin 無
- Chun-Yuan Lee 無
- Jeng-Shiun Du 無
- Tsung-Jang Yeh 無
- 呂其融 無
- 梁智瑋 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Fu-Der Wang 無
- Hsin-Yi Liu 無
- Sheng-Yu Chen 無
- 黃筱雯 無
- 高冠鈞 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wen-Chien Chou 無
- HSIN-YUN SUN 無
- Un-in Wu 無
- SUNG-CHING PAN 無
- CHENG-HONG TSAI 無
- 陳宜君 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-Jen Liu 無
- Ping-Feng Wu 無
- 陳昕白 無
- Chien Chuang 無
- 徐靖浩 無
- 劉思妤 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ho Mao-Wang 無
- Yu-Chao Lin 無
- 蘇浤傑 無
- 鄭孟瑜 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Po-Yan Huang
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Invasive fungal infection
Objectives
To evaluate the efficacy of fosmanogepix in treating adult patients with IMI caused by Aspergillus (for patients with limited treatment options), Fusarium, Lomentospora prolificans, Mucorales fungi, or other multidrug-resistant fungi.
Test Drug
Fosmanogepix
Fosmanogepix
Fosmanogepix
Active Ingredient
Fosmanogepix
Fosmanogepix
Fosmanogepix
Dosage Form
Tablets
Infusion
Infusion
Dosage
400 mg
350 mg/vial
350 mg/vial
Endpoints
To evaluate the efficacy of fosmanogepix in treating adult patients with IMI caused by Aspergillus (for patients with limited treatment options), Fusarium, Lomentospora prolificans, Mucorales fungi, or other multidrug-resistant fungi.
Inclution Criteria
1. Patients must be ≥18 years of age at screening (if the minimum consent age in a specific country is >18 years, the relevant age limit must be met), and have signed an informed consent form/their legal representative must have signed an informed consent form, indicating that they understand the purpose and necessary procedures of this trial and are willing to participate. If the patient is unable to sign the informed consent form themselves, their legal representative must sign it on their behalf.
2. Patients must be diagnosed with confirmed or probable IMI according to the revised and updated IFD consensus definition established by EORTC/MSGERC (adapted for this trial). Patients will be included in one of two groups:
• Group A: Patients with confirmed or probable IMI requiring initial treatment. This group will include patients who have received potentially effective treatment for their current IMI for no more than 96 hours (within the last 7 days prior to randomization).
Patients will be included in four different fungal pathogen groups:
- Aspergillus (for those with limited treatment options as defined below)
- Fusarium
- Lomentospora prolificans
- Mucorales fungi
Patients with Aspergillus infections may be included if treatment options are limited. Limited treatment options are defined as the inability to use triazoles as first-line treatment due to one or more of the following conditions:
a. The isolated strain is resistant to triazoles, based on:
i. In vitro susceptibility testing using the European Committee for Antimicrobial Susceptibility Testing (EUCAST) method, where resistance to azoles is defined as resistance to isavuconazole, posaconazole, or voriconazole according to the following minimum inhibitory concentration (MIC) criteria (Guinea 2020):
• Isavuconazole: MIC > 2 mg/L against *A. fumigatus*, *A. terreus*, and *A. flavus*, and MIC > 0.25 mg/L against *A. nidulans*
• Posaconazole: MIC > 0.25 mg/L against *A. fumigatus* and *A. terreus*
• Voriconazole: MIC > 1 mg/L against *A. fumigatus* and *A. nidulans* mg/L
ii. Molecular identification based on Cyp51A gene resistance mutations, including TR34/L98H, TR46/Y121F/T289A, or single-point mutations (such as G54R/W, P216S, G448S, G432S, M220K/I/R, Y121F, F219S, or TR120/F46Y/M172V/E427K)
b. Development of breakthrough invasive aspergillosis during at least 7 days of prophylactic treatment with systemic isavuconazole, itraconazole, posaconazole, or voriconazole
c. Documented history of azole intolerance to voriconazole, posaconazole, or isavuconazole
d. Due to systemic isavuconazole, itraconazole, posaconazole, or voriconazole resistant to CYP450 Inhibition of 3A4 cannot resolve drug interactions in the following situations:
i. Current or past clinical side effects presumed to be caused by azole-mediated CYP450 3A4/5 inhibition.
ii. Current or past concomitant use of drugs (such as sirolimus, tacrolimus) with fluctuations in blood drug concentrations presumed to be caused by azole-mediated CYP450 3A4/5 inhibition.
iii. The patient requires concomitant use of a sensitive CYP450 3A4/5 receptor drug with a narrow therapeutic concentration range (FDA 2024), and this drug has previously caused drug interactions presumed to be caused by azole-mediated CYP450 3A4/5 inhibition, or there is no prior experience with concomitant use with isavuconazole, itraconazole, posaconazole, or voriconazole.
The following drugs are considered sensitive CYP450 3A4 receptors with narrow therapeutic concentration ranges:
• Alfentanil
• Cyclosporine
• Everolimus
• Ibrutinib
• Lomitapide
• Sirolimus
• Tacrolimus
• Venetoclax Patients using other sensitive CYP450 A4/5 receptors may also be included in the trial, provided prior consultation with and consent from the healthcare provider.
Caution should be exercised when using drugs metabolized by CYP450 A4/5, and the frequency of monitoring blood drug concentrations (if applicable) should be considered, in accordance with the trial center's institutional practices.
If a confirmed or probable IMI diagnosis is not achieved initially, patients with probable IMI at randomization may also be included in the trial, provided they are willing or undergoing the diagnostic process and anticipate a mycological diagnosis of confirmed or probable IMI (an additional mycological specimen collected within 7 days of the first dose of the trial treatment). This randomized fungal species identification may result in updates to the fungal pathogen group (different from the group used at patient enrollment). If no confirmed or probable IMI is identified, patients with possible IMI may continue to participate in the trial but will not be considered in the analysis of the primary trial objective and will be analyzed separately.
• Group B: Patients requiring rescue treatment. This group will include patients with IMI caused by Aspergillus, Fusarium, Lomentospora prolificans, Mucorales fungi, or other multidrug-resistant fungi (including Mycorrhiza) that have received standard-care antifungal therapy for up to 30 days and have experienced intolerance (including inability to manage drug interactions), toxicity, lack of clinical response (after at least 8 days of standard-care antifungal therapy, see Section 6.1.2 for details), and/or have fungal isolates resistant to standard-care antifungal therapy.
3. The patient's condition allows for appropriate source control measures, including:
a. Removal of existing catheters and devices considered potential sources of IMI.
b. Surgical debridement, such as for IMI affecting the sinuses or invasive fungal soft tissue, bone, and joint infections.
2. Patients must be diagnosed with confirmed or probable IMI according to the revised and updated IFD consensus definition established by EORTC/MSGERC (adapted for this trial). Patients will be included in one of two groups:
• Group A: Patients with confirmed or probable IMI requiring initial treatment. This group will include patients who have received potentially effective treatment for their current IMI for no more than 96 hours (within the last 7 days prior to randomization).
Patients will be included in four different fungal pathogen groups:
- Aspergillus (for those with limited treatment options as defined below)
- Fusarium
- Lomentospora prolificans
- Mucorales fungi
Patients with Aspergillus infections may be included if treatment options are limited. Limited treatment options are defined as the inability to use triazoles as first-line treatment due to one or more of the following conditions:
a. The isolated strain is resistant to triazoles, based on:
i. In vitro susceptibility testing using the European Committee for Antimicrobial Susceptibility Testing (EUCAST) method, where resistance to azoles is defined as resistance to isavuconazole, posaconazole, or voriconazole according to the following minimum inhibitory concentration (MIC) criteria (Guinea 2020):
• Isavuconazole: MIC > 2 mg/L against *A. fumigatus*, *A. terreus*, and *A. flavus*, and MIC > 0.25 mg/L against *A. nidulans*
• Posaconazole: MIC > 0.25 mg/L against *A. fumigatus* and *A. terreus*
• Voriconazole: MIC > 1 mg/L against *A. fumigatus* and *A. nidulans* mg/L
ii. Molecular identification based on Cyp51A gene resistance mutations, including TR34/L98H, TR46/Y121F/T289A, or single-point mutations (such as G54R/W, P216S, G448S, G432S, M220K/I/R, Y121F, F219S, or TR120/F46Y/M172V/E427K)
b. Development of breakthrough invasive aspergillosis during at least 7 days of prophylactic treatment with systemic isavuconazole, itraconazole, posaconazole, or voriconazole
c. Documented history of azole intolerance to voriconazole, posaconazole, or isavuconazole
d. Due to systemic isavuconazole, itraconazole, posaconazole, or voriconazole resistant to CYP450 Inhibition of 3A4 cannot resolve drug interactions in the following situations:
i. Current or past clinical side effects presumed to be caused by azole-mediated CYP450 3A4/5 inhibition.
ii. Current or past concomitant use of drugs (such as sirolimus, tacrolimus) with fluctuations in blood drug concentrations presumed to be caused by azole-mediated CYP450 3A4/5 inhibition.
iii. The patient requires concomitant use of a sensitive CYP450 3A4/5 receptor drug with a narrow therapeutic concentration range (FDA 2024), and this drug has previously caused drug interactions presumed to be caused by azole-mediated CYP450 3A4/5 inhibition, or there is no prior experience with concomitant use with isavuconazole, itraconazole, posaconazole, or voriconazole.
The following drugs are considered sensitive CYP450 3A4 receptors with narrow therapeutic concentration ranges:
• Alfentanil
• Cyclosporine
• Everolimus
• Ibrutinib
• Lomitapide
• Sirolimus
• Tacrolimus
• Venetoclax Patients using other sensitive CYP450 A4/5 receptors may also be included in the trial, provided prior consultation with and consent from the healthcare provider.
Caution should be exercised when using drugs metabolized by CYP450 A4/5, and the frequency of monitoring blood drug concentrations (if applicable) should be considered, in accordance with the trial center's institutional practices.
If a confirmed or probable IMI diagnosis is not achieved initially, patients with probable IMI at randomization may also be included in the trial, provided they are willing or undergoing the diagnostic process and anticipate a mycological diagnosis of confirmed or probable IMI (an additional mycological specimen collected within 7 days of the first dose of the trial treatment). This randomized fungal species identification may result in updates to the fungal pathogen group (different from the group used at patient enrollment). If no confirmed or probable IMI is identified, patients with possible IMI may continue to participate in the trial but will not be considered in the analysis of the primary trial objective and will be analyzed separately.
• Group B: Patients requiring rescue treatment. This group will include patients with IMI caused by Aspergillus, Fusarium, Lomentospora prolificans, Mucorales fungi, or other multidrug-resistant fungi (including Mycorrhiza) that have received standard-care antifungal therapy for up to 30 days and have experienced intolerance (including inability to manage drug interactions), toxicity, lack of clinical response (after at least 8 days of standard-care antifungal therapy, see Section 6.1.2 for details), and/or have fungal isolates resistant to standard-care antifungal therapy.
3. The patient's condition allows for appropriate source control measures, including:
a. Removal of existing catheters and devices considered potential sources of IMI.
b. Surgical debridement, such as for IMI affecting the sinuses or invasive fungal soft tissue, bone, and joint infections.
Exclusion Criteria
1. Refractory hematologic malignancies with no potential response to additional chemotherapy, or uncontrolled malignancies unresponsive to current treatment despite curative or palliative chemotherapy.
2. Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
3. COVID-19-related white mold infection.
4. Invasive fungal diseases caused by more than one fungal pathogen are not permitted in Group A, but are permitted in Group B.
5. Patients with a Karnofsky Performance Status score < 20 at screening.
6. Patients who require or are expected to require hemodialysis, peritoneal dialysis, or hemofiltration.
7. Patients with a CD4+ count < 200 mm3 and/or a viral load > 400 copies/mL, or patients with a known human immunodeficiency virus infection with active opportunistic infection within 6 months prior to screening.
8. Persistent neurological disorders, including specific conditions such as CTCAE ≥ Grade 2 (unless related to IMI).
9. Patients receiving only palliative care/comfort care.
10. Other medical or psychiatric conditions (including recent [within the past year] or active suicidal ideation/behavior) or abnormal laboratory tests that may increase the risk of trial participation, or, in the judgment of the investigating physician, may render the patient unsuitable for trial participation or interfere with the ability to perform trial assessments.
11. Patients currently using any prohibited concomitant medications or who are unwilling/unable to use permitted concomitant medications.
12. Patients who have received any investigational drug in any clinical trial within 30 days prior to the first dose of the investigational drug, except for treatment strategy trials using approved compounds, prospective registry studies, or diagnostic/biomarker trials. Note: Local regulations or other factors may require a period exceeding 30 days. An investigational drug is defined as a drug not approved for any indication in any country.
13. Patients previously enrolled in this trial or any previous fosmanogepix trial.
14. Moderate or severe liver injury, known active hepatitis B or C, alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 5 × upper limit of normal (ULN), or total bilirubin > 3 × ULN, unless caused by isolated hyperbilirubinemia or documented Gilbert’s syndrome.
15. Staff of the trial physician's institution directly involved in the execution of the trial and their families, staff of other trial units managed by the trial physician, and staff appointed by the trial commissioner directly involved in the execution of the trial and their families.
16. Pregnant or breastfeeding patients.
17. Known allergy to fosmanogepix, manogepix, or any of its excipients.
2. Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
3. COVID-19-related white mold infection.
4. Invasive fungal diseases caused by more than one fungal pathogen are not permitted in Group A, but are permitted in Group B.
5. Patients with a Karnofsky Performance Status score < 20 at screening.
6. Patients who require or are expected to require hemodialysis, peritoneal dialysis, or hemofiltration.
7. Patients with a CD4+ count < 200 mm3 and/or a viral load > 400 copies/mL, or patients with a known human immunodeficiency virus infection with active opportunistic infection within 6 months prior to screening.
8. Persistent neurological disorders, including specific conditions such as CTCAE ≥ Grade 2 (unless related to IMI).
9. Patients receiving only palliative care/comfort care.
10. Other medical or psychiatric conditions (including recent [within the past year] or active suicidal ideation/behavior) or abnormal laboratory tests that may increase the risk of trial participation, or, in the judgment of the investigating physician, may render the patient unsuitable for trial participation or interfere with the ability to perform trial assessments.
11. Patients currently using any prohibited concomitant medications or who are unwilling/unable to use permitted concomitant medications.
12. Patients who have received any investigational drug in any clinical trial within 30 days prior to the first dose of the investigational drug, except for treatment strategy trials using approved compounds, prospective registry studies, or diagnostic/biomarker trials. Note: Local regulations or other factors may require a period exceeding 30 days. An investigational drug is defined as a drug not approved for any indication in any country.
13. Patients previously enrolled in this trial or any previous fosmanogepix trial.
14. Moderate or severe liver injury, known active hepatitis B or C, alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 5 × upper limit of normal (ULN), or total bilirubin > 3 × ULN, unless caused by isolated hyperbilirubinemia or documented Gilbert’s syndrome.
15. Staff of the trial physician's institution directly involved in the execution of the trial and their families, staff of other trial units managed by the trial physician, and staff appointed by the trial commissioner directly involved in the execution of the trial and their families.
16. Pregnant or breastfeeding patients.
17. Known allergy to fosmanogepix, manogepix, or any of its excipients.
The Estimated Number of Participants
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Taiwan
35 participants
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Global
220 participants
