Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
514G3 plus standard antibiotic treatment · 1 trial · 1 indication
Dose limiting Toxicity are defined as any Grade 3 or greater AE which is probably or definitely related to 514G3 occurring during the FU period after dosing. This measure determines and assesses the maximum tolerated dose (MTD) through participants who experienced DLT at different dose levels.
A summary of SAEs and other non-serious AEs, regardless of causality
| Arm | Type | Description |
|---|---|---|
| Phase I | EXPERIMENTAL | A phase I of the trial is a dose escalation study intended to assess the possible toxicity and to determine the recommended phase 2 dose (RP2D) of the study drug (514G3). Randomized subjects were administered the study drug at 3 dose levels i.e. 2 mg/kg, 10 mg/kg, and 40 mg/kg or placebo. |
| Phase II | EXPERIMENTAL | A phase 2 of the trial is a dose expansion study designed to assess the preliminary efficacy. Eligible subjects are randomized (2:1) and received a single dose of 40 mg/kg study drug (514G3) with standard IV treatment versus placebo with standard IV treatment. |
| Name | Type | Description |
|---|---|---|
| 514G3 (2 mg/kg) plus standard IV antibiotic treatment | BIOLOGICAL | - |
| 514G3 (10 mg/kg) plus standard IV antibiotic treatment | BIOLOGICAL | - |
| 514G3 (40 mg/kg) plus standard IV antibiotic treatment | BIOLOGICAL | - |
| Placebo plus standard IV antibiotic treatment | OTHER | Sterile isotonic formulation buffered at pH 6.2 - 6.5 plus standard IV antibiotic treatment |
| 514G3 (40 mg/kg) plus standard IV antibiotic treatment: Phase II | BIOLOGICAL | A single dose of 514G3 plus standard IV antibiotic therapy |
| Placebo plus standard IV antibiotic treatment: Phase II | OTHER | A single dose of placebo plus standard IV antibiotic therapy |
Inclusion Criteria: 1. One or more blood cultures positive for staphylococcus aureus within 2 days of initiating treatment with 514G3. 2. Temperature ≥ 38.0°C 3. Age ≥18, male or female subjects. 4. Adequate renal function, defined by serum creatinine ≤ 2 times the upper limit of normal (ULN). 5. A...
514G3 plus standard antibiotic treatment is an investigational monoclonal antibody therapy given alongside standard intravenous antibiotics to treat Staphylococcus aureus bacteremia, a bloodstream infection. It was studied in hospitalized adults aged 18 and older. The antibody component is designed to be given as an add-on to conventional antibiotic care rather than as a replacement for it.
It is being studied for Staphylococcus aureus bacteremia, a serious bloodstream infection caused by Staphylococcus aureus bacteria. The treatment combines the monoclonal antibody 514G3 with standard intravenous antibiotics in hospitalized patients. The goal of adding the antibody is to support the body's response to the infection alongside conventional antibiotic therapy.
514G3 is developed by XBiotech Inc., which trades on the Nasdaq under the ticker XBIT. The company sponsored the clinical research evaluating the antibody in combination with standard intravenous antibiotics for Staphylococcus aureus bacteremia. XBiotech is a clinical-stage biopharmaceutical company focused on antibody therapeutics.
514G3 plus standard antibiotic treatment has been studied in a Phase 1 clinical trial. It is an investigational therapy and is not approved by the FDA. The Phase 1 program has been completed, and no trials of this combination are currently listed as active.
The combination was evaluated in one completed Phase 1 trial, NCT02357966, titled Safety & Efficacy of True Human Antibody, 514G3, in Staphylococcus Aureus Bacteremia Hospitalized Subjects. The trial enrolled 52 participants in the United States, was randomized, double blind, and controlled, and included adults aged 18 years and older of all sexes.