Recruiting
Phase 2

Gruticibart

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT07498517

Conditions

Thrombosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Placebo

Gruticibart

Ultrasound

Biopspecimen collection

Study Details

Brief summary:

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.

Conditions

Thrombosis

Study ID

NCT07498517

Start date

Aug 6, 2026

Status verified date

Aug, 2026

Completion date

Oct 2, 2029

Anticipated

Primary completion date

Feb 2, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Arm A: Placebo

Placebo

experimental: Arm B: Gruticibart

Gruiticibart

Interventions

Placebo

Given IV or via catheter

Gruticibart

2mg/kg, Given IV or via catheter

Ultrasound

Undergo ultrasound of CVC and both legs for Deep Vein Thrombosis (DVTs )

Biopspecimen collection

Undergo blood sample collection

Primary outcome measure

  • Number of participants with catheter-related thrombosis [ Time Frame: Day 1 to end of follow up (up to 14 days) ]
  • Incidence of major and clinically-relevant bleeding [ Time Frame: Day 1 up to end of treatment (up to 14 days) ]

Central Contacts and Locations

Locations

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Joseph Shatzel, M.D.

503-494-6594shatzel@ohsu.edu

Principal Investigator:

Joseph Shatzel, M.D.

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2026-08-31. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.