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Comparing two treatments for blood clots in cancer patients

A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab vs. Dalteparin on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With GI/GU Associated VTE

Phase 3 Interventional Anthos Therapeutics, Inc. · NCT05171075

This study is testing whether a new treatment called abelacimab is better than the standard medication dalteparin at preventing blood clots and bleeding in cancer patients who have already had blood clots.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1020 (estimated)
Ages18 Years and up
SexAll
SponsorAnthos Therapeutics, Inc. Industry-sponsored
Drugs / interventionsabelacimab
Locations185 sites (Aurora, Colorado and 184 other locations)
Trial IDNCT05171075 on ClinicalTrials.gov

What this trial studies

This Phase 3, multicenter, open-label study evaluates the effectiveness of abelacimab compared to dalteparin in preventing venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal and genitourinary cancers. The study focuses on patients who have experienced deep vein thrombosis or pulmonary embolism associated with their cancer. Participants will receive either monthly abelacimab or daily subcutaneous dalteparin for six months, with outcomes measured for VTE recurrence, bleeding events, and treatment discontinuation. The study aims to address the high risk of VTE recurrence and bleeding in this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates include adults with unresectable or advanced gastrointestinal or genitourinary cancers who have experienced a recent venous thromboembolism.

Not a fit: Patients who have undergone recent thrombectomy or have contraindications to anticoagulation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and safer treatment option for cancer patients at risk of blood clots.

How similar studies have performed: Other studies have shown promising results with similar anticoagulant approaches, but this specific comparison is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male or female subjects ≥18 years old or other legal maturity age according to the country of residence
* Confirmed GI (colorectal, pancreatic, gastric, esophageal, gastro-esophageal junction or hepatobiliary) or confirmed GU (renal, ureteral, bladder, prostate, or urethra) cancers if:

  * Unresectable, locally advanced, metastatic, or non-metastatic GI/GU cancer and
  * No intended curative surgery during the study
* Confirmed symptomatic or incidental proximal lower limb deep vein thrombosis (DVT) (i.e., popliteal, femoral, iliac, and/or inferior vena cava vein thrombosis) and/or a confirmed symptomatic pulmonary embolism (PE), or an incidental PE in a segmental, or larger pulmonary artery. Patients are eligible within 120 hours from diagnosis of the qualifying VTE.
* Anticoagulation therapy with LMWH for at least 6 months is indicated
* Able to provide written informed consent

Exclusion Criteria:

* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) occurrence of DVT and/or PE
* More than 120 hours of pre-treatment with therapeutic doses of UFH, LMWH, or other anticoagulants
* An indication to continue treatment with therapeutic doses of an anticoagulant other than for VTE treatment prior to randomization (e.g., atrial fibrillation, mechanical heart valve, prior VTE)
* PE leading to hemodynamic instability (systolic BP \<90 mmHg or shock).
* Acute ischemic or hemorrhagic stroke or intracranial hemorrhage, in the last 4 weeks preceding screening.
* Brain trauma, or cerebral or a spinal cord surgery or spinal procedures such as lumbar puncture or epidural/spinal anesthesia within 4 weeks of screening
* Need for aspirin in a dosage of more than 100 mg/day or, any other antiplatelet agent alone or in combination with aspirin
* Bleeding requiring medical attention at the time of randomization or in the preceding 4 weeks
* Planned brain, spinal cord, cardiac, vascular, major thoracic and/or major abdominal surgery in the 4 weeks following randomization
* History of heparin induced thrombocytopenia
* Infective acute or subacute endocarditis at the time of presentation
* Primary brain cancer or untreated intracranial metastasis
* Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4 at screening
* Life expectancy of \<3 months at randomization
* Calculated creatinine clearance (CrCl) \<30 mL/min at the screening visit
* Platelet count \<50,000/ mm3 at the screening visit
* Hemoglobin \<8 g/dL at the screening visit
* Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase ≥3 times and/or bilirubin ≥2 times the upper limit of normal (ULN) at the screening visit in the absence of clinical explanation
* Uncontrolled hypertension (systolic blood pressure \[BP\] \> 180 mm Hg or diastolic BP \>100 mm Hg despite antihypertensive treatment)
* Women of child-bearing potential (WOCBP) who are unwilling or unable to use highly effective contraceptive measures during the study from screening up to 3 days after last treatment of dalteparin or 100 days after administration of abelacimab
* Sexually active males with sexual partners of childbearing potential must agree to use a condom or other reliable contraceptive measure up to 3 days after last treatment of dalteparin or 100 days after administration of abelacimab
* Pregnant or breast-feeding women
* History of hypersensitivity to any of the study drugs (including dalteparin) or its excipients, to drugs of similar chemical classes, or any contraindication listed in the label for dalteparin
* Subjects with any condition that in the judgement of the Investigator would place the subject at increased risk of harm if he/she participated in the study
* Use of other investigational (not-registered) drugs within 5 half-lives prior to enrollment or until the expected pharmacodynamic effect has returned to baseline, whichever is longer. Participation in academic non-interventional studies or interventional studies, comprising testing different strategies or different combinations of registered drugs is permitted.

Where this trial is running

Aurora, Colorado and 184 other locations

+135 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Venous ThromboembolismDeep Venous ThrombosisPulmonary EmbolismAnticoagulantsVTE recurrence ratePROBE designLMWHCAT
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.