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

Stopped early · Phase 3

Conditions studied: Venous Thromboembolism, Deep Venous Thrombosis, Pulmonary Embolism

In brief

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)

Key facts

Study ID: NCT05171075
Run by: Anthos Therapeutics, Inc.
People needed: 417
Starts: 2022-09-27
Expected to finish: 2026-04-10
Last updated by the study team: 2026-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 it is running

NorthShore University Health System — Evanston, Illinois, United States
Barnes-Jewish Hospital — St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center-Middletown — Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center-Commack — Commack, New York, United States
Memorial Sloan Kettering Cancer Center-West Harrison — Harrison, New York, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Weill Cornell Medical College — New York, New York, United States
Duke University Medical Center — Durham, North Carolina, United States
University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
Blacktown Hospital — Blacktown, New South Wales, Australia
Westmead Hospital — Westmead, New South Wales, Australia
Northern Health — Epping, Victoria, Australia
LK Wiener Neustadt — Neustadt, Austria
Medical University of Vienna — Vienna, Austria
Hamilton Health Sciences, Juravinski Hospital and Cancer Centre — Hamilton, Ontario, Canada
Ottawa Hospital Research Instituite — Ottawa, Ontario, Canada
Ottawa Hospital Research Instituite — Ottawa, Ontario, Canada
University of Calgary — Calgary, Canada
Sault Area Hospital — Marie, Canada
Toronto General Hospital — Toronto, Canada
Beijing Shijitan Hosp. — Beijing, China
Peking University Third Hospital — Beijing, China
Jilin Province Tumor Hospital — Ch’ang-ch’un, China
Southern Medical University - Zhujiang Hospital — Guangdong, China
Washington DC VAMC — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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