For Healthcare Professionals

A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE


About the study

This is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia)

Who can take part

You may be eligible to participate in the study if you meet the following 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:

  1. Unresectable, locally advanced, metastatic, or non-metastatic GI/GU cancer and
  2. No intended curative surgery during the study
  3. 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.
  4. Anticoagulation therapy with LMWH for at least 6 months is indicated
  5. Able to provide written informed consent


Exclusion Criteria:

  1. Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) occurrence of DVT and/or PE
  2. More than 120 hours of pre-treatment with therapeutic doses of UFH, LMWH, or other anticoagulants
  3. 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)
  4. PE leading to hemodynamic instability (systolic BP <90 mmHg or shock).
  5. Acute ischemic or hemorrhagic stroke or intracranial hemorrhage, in the last 4 weeks preceding screening.
  6. 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
  7. Need for aspirin in a dosage of more than 100 mg/day or, any other antiplatelet agent alone or in combination with aspirin
  8. Bleeding requiring medical attention at the time of randomization or in the preceding 4 weeks
  9. Planned brain, spinal cord, cardiac, vascular, major thoracic and/or major abdominal surgery in the 4 weeks following randomization
  10. History of heparin induced thrombocytopenia
  11. Infective acute or subacute endocarditis at the time of presentation
  12. Primary brain cancer or untreated intracranial metastasis
  13. Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4 at screening
  14. Life expectancy of <3 months at randomization
  15. Calculated creatinine clearance (CrCl) <30 mL/min at the screening visit
  16. Platelet count <50,000/ mm3 at the screening visit
  17. Hemoglobin <8 g/dL at the screening visit
  18. 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
  19. Uncontrolled hypertension (systolic blood pressure [BP] > 180 mm Hg or diastolic BP >100 mm Hg despite antihypertensive treatment)
  20. 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
  21. 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
  22. Pregnant or breast-feeding women
  23. 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
  24. 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
  25. 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.
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Study Locations

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How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Venous Thromboembolism,Deep Venous Thrombosis,Pulmonary Embolism

Age (in years)



Phase 3

Participants needed


Est. Completion Date

Jan 31, 2025

Treatment type



Anthos Therapeutics, Inc. identifier


Study number


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