Safety and Efficacy of a Single Dose of Gruticibart to Prevent CRT

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Thrombosis

In brief

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.

Key facts

Study ID: NCT07498517
Run by: OHSU Knight Cancer Institute
People needed: 90
Starts: 2026-02-28
Expected to finish: 2029-10-02
Last updated by the study team: 2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Concurrent enrollment in another therapeutic clinical trial
Active leukemia (lymphoma and myeloma may be included)
Primary brain tumors or known brain metastases
Active infection and/or current use of an oral antibiotic
At time of enrollment:
Deranged baseline clotting, where INR > 1.5
Known bleeding diathesis
Use of anticoagulation, either therapeutic or prophylactic, for any indication at enrollment
-At the discretion of the investigator, any other contraindication to anticoagulation therapy
Previously documented hypersensitivity to either the drug or excipients.
Psychiatric illness/social situations, or any other condition, that in the opinion of the investigator, would limit compliance with study requirements.
Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 90 days after study drug administration.

Where it is running

OHSU Knight Cancer Institute — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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