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

NCT06678113 | Recruiting Phase 1 DMC

• 1 other identifier: BSG-1.02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Invasive Fungal Infection

Keywords

Invasive fungal infection; BSG005; Polyene macrolide; Rescue therapy

Outcome Measures

Primary Outcomes (2)

• To establish the safety and tolerability of BSG005 in patients with severe invasive fungal infection

  Treatment Emergent Adverse Event (CTC grading of severity)

  From enrollment to end of treamtent including 14 days follow up

• To establish the safety and tolerability of BSG005 in patients with severe invasive fungal infection

  Renal function (eGFR)

  From enrollment to end of treamtent including 14 days follow up

Secondary Outcomes (2)

• To assess the overall response to BSG005 treatment in patients with invasive fungal infection

  From treatment start to end of treatment plus 14 days follow up

• To assess the overall response to BSG005 treatment in patients with invasive fungal

  From treatment start to end of treatment plus 14 days follow up

Study Arms (1)

Active treatment

EXPERIMENTAL

The patient will receive active treatment in a dose escalation manner increasing the dose every 3 days dependent on safety and efficacy

Drug: BSG005

Interventions

BSG005 DRUG

Single arm dose escalation in patients with invasive fungal infection

Also known as: Polyene Macrolide

Active treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• Biosergen AS: lead
• Alkem Laboratories Ltd: collaborator
• JSS Medical Research Asia pacific Private Limited: collaborator

Study Sites (1)

JSS Medical Research Asia Pacific Private Limited

Dehli, Haryana, 121003, India

RECRUITING

MeSH Terms

Conditions

Invasive Fungal Infections

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Tine Olesen, PhD

  BIOSERGEN AB

  STUDY CHAIR

Central Study Contacts

Tine Olesen, CEO

CONTACT

+4531355707; tine.olesen@biosergen.net

Niels Laursen, CFO

CONTACT

+4540145059; niels.laursen@biosergen.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: November 7, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The information will be available after end of study when the clinical trial report is written
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact tine.olesen@biosergen.net

Locations

IN (1)