A Multicenter rAndomized, open-label, blinded endpoint evaluation, phase 3 study comparinG the effect of abelacimab relative to daltepariN on venOus thromboLism (VTE) recurrence and bleeding in patients with gastroIntestinal (GI)/genitourinAry (GU) cancer associated VTE (Magnolia)

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)

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.