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

Inclusion Criteria:

• Male or female subjects ≥18 years old or other legal maturity age according to thecountry of residence

• Confirmed GI (colorectal, pancreatic, gastric, esophageal, gastro-esophagealjunction or hepatobiliary) or confirmed GU (renal, ureteral, bladder, prostate, orurethra) 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/ora confirmed symptomatic pulmonary embolism (PE), or an incidental PE in a segmental,or larger pulmonary artery. Patients are eligible within 120 hours from diagnosis ofthe 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 treatthe current (index) occurrence of DVT and/or PE

• More than 120 hours of pre-treatment with therapeutic doses of UFH, LMWH, or otheranticoagulants

• An indication to continue treatment with therapeutic doses of an anticoagulant otherthan for VTE treatment prior to randomization (e.g., atrial fibrillation, mechanicalheart 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 weekspreceding screening.

• Brain trauma, or cerebral or a spinal cord surgery or spinal procedures such aslumbar 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 antiplateletagent alone or in combination with aspirin

• Bleeding requiring medical attention at the time of randomization or in thepreceding 4 weeks

• Planned brain, spinal cord, cardiac, vascular, major thoracic and/or major abdominalsurgery 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 alanineaminotransferase ≥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 highlyeffective contraceptive measures during the study from screening up to 3 days afterlast treatment of dalteparin or 100 days after administration of abelacimab

• Sexually active males with sexual partners of childbearing potential must agree touse a condom or other reliable contraceptive measure up to 3 days after lasttreatment 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 itsexcipients, to drugs of similar chemical classes, or any contraindication listed inthe label for dalteparin

• Subjects with any condition that in the judgement of the Investigator would placethe 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 toenrollment or until the expected pharmacodynamic effect has returned to baseline,whichever is longer. Participation in academic non-interventional studies orinterventional studies, comprising testing different strategies or differentcombinations of registered drugs is permitted.