drugset / Trial / NCT04763759
Study to Evaluate Safety and Activity of TRL1068 in Prosthetic Joint Infections
Phase 1
Completed
15 enrolled
Trellis Bioscience LLC
Biomedical Advanced Research and Development Authority · collabGulfcoast Research Institute · collabPhoenix Clinical Research · collabSinai Hospital of Baltimore · collabThe Methodist Hospital Research Institute · collabUniversity of Alabama at Birmingham · collabUniversity of California, Los Angeles · collabUniversity of Florida · collabUniversity of Southern California · collabUniversity of Virginia · collabWellcome Trust · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making these pathogens substantially more susceptible to established antibiotic treatment regimens. This initial study is designed to assess overall safety and pharmacokinetics (PK) of TRL1068. The overall goal of the development program is to demonstrate that TRL1068 can facilitate effectiveness of a single stage joint replacement or preservation of the original infected prosthetic joint in a substantial proportion of patients with PJI.
Timeline
- Start
- 2021-02-08
- Primary completion
- 2024-03-13
- Completion
- 2024-03-13
Publications
- Background Estelles A, Woischnig AK, Liu K, Stephenson R, Lomongsod E, Nguyen D, Zhang J, Heidecker M, Yang Y, Simon RJ, Tenorio E, Ellsworth S, Leighton A, Ryser S, Gremmelmaier NK, Kauvar LM. A High-Affinity Native Human Antibody Disrupts Biofilm from Staphylococcus aureus Bacteria and Potentiates Antibiotic Efficacy in a Mouse Implant Infection Model. Antimicrob Agents Chemother. 2016 Mar 25;60(4):2292-301. doi: 10.1128/AAC.02588-15. Print 2016 Apr.
- Background Xiong YQ, Estelles A, Li L, Abdelhady W, Gonzales R, Bayer AS, Tenorio E, Leighton A, Ryser S, Kauvar LM. A Human Biofilm-Disrupting Monoclonal Antibody Potentiates Antibiotic Efficacy in Rodent Models of both Staphylococcus aureus and Acinetobacter baumannii Infections. Antimicrob Agents Chemother. 2017 Sep 22;61(10):e00904-17. doi: 10.1128/AAC.00904-17. Print 2017 Oct.
- Results Conway J, Delanois RE, Mont MA, Stavrakis A, McPherson E, Stolarski E, Incavo S, Oakes D, Salvagno R, Adams JS, Kisch-Hancock A, Tenorio E, Leighton A, Ryser S, Kauvar LM, Bernthal NM. Phase 1 study of the pharmacokinetics and clinical proof-of-concept activity of a biofilm-disrupting human monoclonal antibody in patients with chronic prosthetic joint infection of the knee or hip. Antimicrob Agents Chemother. 2024 Aug 7;68(8):e0065524. doi: 10.1128/aac.00655-24. Epub 2024 Jul 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | calpurbatug | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | calpurbatug | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | calpurbatug | Monoclonal antibody | 30 mg/kg | Intravenous |