A Study to Evaluate the Safety and Efficacy of a Single Dose of Gruticibart for the Prevention of Early Catheter-related Thrombosis
This phase II trial studies how well gruticibart works in reducing the incidence of catheter-related thrombosis (CRT) blood clots in patients with a central venous catheter (CVC) inserted. Many patients develop blood clots from their catheters and can have pain, swelling, and other symptoms. They also often require blood thinners, which can increase the risk of bleeding. Gruticibart, a type of drug called a monoclonal antibody, may prevent blood clots caused by a catheter.
• Ability to understand and the willingness to sign a written informed consent document.
• Men and women, aged ≥ 18 years.
• In consultation with PI and treating physician, participant's therapy allows for a 1 to 2-day period between administration of study drug and subsequent start of planned therapy.
• Individuals that will undergo insertion of a CVC as part of planned therapy per institutional standards.
• Must have ECOG performance status ≤ 2 (refer to Appendix A).
• At time of enrollment, must have:
⁃ Platelet count \> 50 x 109/L
• Female participants of childbearing potential must have a negative urine or serum pregnancy test during screening and at check-in Day -1. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Participants of childbearing potential are defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal.
• Female participants of childbearing potential must agree to use two forms of highly effective contraception (Appendix B) starting with the first dose of study therapy through 90 days after the last dose of study therapy.
‣ Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \>1 year without an alternative medical cause.
• Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy.