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Comparing abelacimab and apixaban for treating blood clots in cancer patients

A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab Relative to Apixaban on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With Cancer Associated VTE

Phase 3 Interventional Anthos Therapeutics, Inc. · NCT05171049

This study is testing whether a new medication called abelacimab is better than the standard blood thinner apixaban at preventing blood clots from coming back in cancer patients.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1655 (estimated)
Ages18 Years and up
SexAll
SponsorAnthos Therapeutics, Inc. Industry-sponsored
Drugs / interventionsabelacimab, chemotherapy
Locations219 sites (Aurora, Colorado and 218 other locations)
Trial IDNCT05171049 on ClinicalTrials.gov

What this trial studies

This Phase 3, multicenter, randomized, open-label study evaluates the effectiveness of abelacimab compared to apixaban in preventing the recurrence of venous thromboembolism (VTE) in patients with cancer-associated thrombosis. The study aims to address the limitations of current treatments, particularly for patients who may struggle with oral medications due to their cancer treatment. Participants will receive either monthly abelacimab or twice-daily apixaban for six months, with outcomes measured in terms of VTE recurrence, bleeding events, and treatment discontinuation. The study is designed to provide insights into the safety and efficacy of these two anticoagulants in a vulnerable patient population.

Who should consider this trial

Good fit: Ideal candidates include adults with active cancer and confirmed cases of deep vein thrombosis or pulmonary embolism.

Not a fit: Patients with non-cancer-related VTE or those who do not meet the inclusion criteria 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 VTE.

How similar studies have performed: Previous studies have shown promise in using novel anticoagulants for VTE treatment, but this specific comparison is relatively 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 diagnosis of cancer (by histology, adequate imaging modality), other than basal-cell or squamous-cell carcinoma of the skin alone with one of the following:

  * Active cancer, defined as either locally active, regionally invasive, or metastatic cancer at the time of randomization and/or
  * Currently receiving or having received anticancer therapy (radiotherapy, chemotherapy, hormonal therapy, any kind of targeted therapy or any other anticancer therapy) in the last 6 months.
* Confirmed symptomatic or incidental proximal lower limb deep vein thrombosis (DVT) (i.e., popliteal, femoral, iliac, and/or inferior vena cava \[IVC\] 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 a therapeutic dose of DOAC 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) DVT and/or PE
* More than 120 hours of pre-treatment with therapeutic doses of UFH, LMWH, fondaparinux, DOAC, or other anticoagulants
* An indication to continue treatment with therapeutic doses of an anticoagulant other than that VTE treatment prior to randomization (e.g., atrial fibrillation \[AF\], mechanical heart valve, prior VTE)
* Platelet count \<50,000/mm3 at the screening visit
* PE leading to hemodynamic instability (blood pressure \[BP\] \<90 mmHg or shock)
* Acute ischemic or hemorrhagic stroke or intracranial hemorrhage within the 4 weeks preceding screening
* Brain trauma or a cerebral or 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 \>100 mg/day or any other antiplatelet agent alone or in combination with aspirin
* Primary brain cancer or untreated intracranial metastases at baseline
* Acute myeloid or lymphoid leukemia
* 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
* Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4 at screening
* Life expectancy \<3 months at randomization
* Calculated creatinine clearance (CrCl) \<30 mL/min (Cockcroft-Gault equation) at the screening visit
* Hemoglobin \<8 g/dL at the screening visit
* Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase (ALT) ≥3 x and/or bilirubin ≥2 x upper limit of normal (ULN) at the screening visit in absence of clinical explanation
* Uncontrolled hypertension (systolic 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 apixaban or 100 days after administration of abelacimab (See Section 5.3.6. for highly effective contraceptive measures)
* 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 apixaban or 100 days after administration of abelacimab
* Pregnant or breast-feeding women
* Patients known to be receiving strong dual inducers or inhibitors of both CYP3A4 and P gp
* History of hypersensitivity to any of the study drugs (including apixaban) or excipients, to drugs of similar chemical classes, or any contraindication listed in the label for apixaban
* Subjects with any condition that in the Investigator's judgement 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(s) (PD) 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 218 other locations

+169 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.