Study to Assess the Safety and Efficacy of Intravenous BSG005 in Patients With Invasive Fungal Infection

Recruiting now · Phase 1/Phase 2

Conditions studied: Invasive Fungal Infection

In brief

This study is an open-label, Phase 1b, dose-escalation/finding study to assess the safety and efficacy of intravenous BSG005 in patients with uncomplicated invasive fungal infections (IFI). Approximately 15 patients are planned to be enrolled in 3 cohorts. The study will be conducted in 3 cohorts consisting of 3 periods, namely: Screening, Treatment, and Follow-up periods. In each cohort, 5 patients are planned to be enrolled. This study is a single-arm study. The treatment (BSG005) in each dose level will be administered once daily for 3 days via IV infusion. If the safety and tolerability profiles are acceptable at each dose level, the patients will be treated for a maximum of 28 days. Each patient will be in the study for up to 50 days, which consists of a 7-day Screening period, 1 day for baseline assessments, up to 28 days (maximum) of treatment with BSG005, and 14 days of follow-up.

Key facts

Study ID: NCT06678113
Run by: Biosergen AS
People needed: 15
Starts: 2024-07-01
Expected to finish: 2026-04-01
Last updated by the study team: 2025-04-06

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 18 years.
Able to provide written informed consent or have a legally authorized representative that can provide informed consent in case of incapacitation.
Diagnosed by Investigator to have an IFI.
Proven IFIs as defined in the 2020 consensus definitions by the European Organization for Research and Treatment of Cancer/ Mycoses Study Group Education and Research Consortium (EORTC/MSGERC). Probable or possible IFIs can be included using the EORTC/MSGERC criteria or other established criteria. The inclusion of patients with IFI caused by, eg, Aspergillus spp and Candida spp, is preferred as these species are generally known to be responsive to a lower dose than other species, eg, Mucor mycosis
IFI patients with mild to moderate renal impairment or IFI patients requiring an alternative treatment as current treatment cannot be continued due to any of the following
Failure with one first-line agent, defined as either: Radiologic progression, Increase in serologic markers such as galactomannan antigen or beta-D-glucan, Failure of clearance of cultures , Progression or lack of improvement in a clinically appropriate timeframe of clinical symptoms attributed to IFI;
Inability to tolerate AmB, as defined by at least one of the following: Nephrotoxicity with either: 1.5 mg/dL increase in creatinine from baseline, 50% increase in creatinine from baseline ii. Contraindication to use AmB with either:- Persistent hypokalemia or hypomagnesemia while on AmB despite appropriate electrolyte replacement
Documented in vitro resistance to first-line antifungal therapy (ie fluconazole resistance in Candida auris)
Treatment-limiting drug-drug interactions prohibiting the use of antifungals (azoles and echinocandins) such as concurrent rifampcin, rifabutin, phenytoin, carbamazepine, bedaqualine

You may not qualify if…

Patient has a known hypersensitivity or severe infusion-related reaction to any polyene drug.
Infection caused by a known or suspected organism with intrinsic resistance to AmB.
Concurrent use of another investigational agent within 30 days of enrollment.
Chronic kidney disease with estimated glomerular filtration rate (eGFR) less than 30 mL/min or dialysis. Patients with acute kidney injury with eGFR less than 30 mL/min and improving creatinine level can be included as judged by the Investigator.
Note: Patients may be rescreened within 48 hours if laboratory values are found to be abnormal.
Has liver enzyme results (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) greater than 5 times the upper limit of normal.
Note: Patients may be rescreened within 48 hours if laboratory values are found to be abnormal.
Has a bilirubin level greater than 5 times the upper limit of normal. Note: Patients may be rescreened within 48 hours if laboratory values are found to be abnormal.
Patients who have an ejection fraction less than 25% of predicted.
Currently pregnant or planning on getting pregnant while on study (details of contraception guidance are provided in Section 13).
Breastfeeding.
Patients not likely to survive a minimum of 28 days from start of screening.
Patient receiving prohibited medications.
Patient is an abuser of alcohol or medication.

Where it is running

JSS Medical Research Asia Pacific Private Limited — Dehli, Haryana, India (enrolling)

Full record on ClinicalTrials.gov

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