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 (ASTER)

Adult male or female subjects are eligible for study participation if they have
confirmed diagnosis of cancer (other than basal-cell or squamous cell carcinoma
of the skin) and presentation with acute VTE (venous thromboembolism), for
which long-term treatment with direct oral anticoagulants (DOACs) is indicated.

Standard of care treatments in such cases include blood thinners
(anticoagulants), such as apixaban (Eliquis®) or low molecular weight heparin,
which helps treat blood clots and reduce the risk of complications that blood
clots can cause, like a stroke, but they can increase the risk of bleeding.

Abelacimab is an experimental drug also referred to as the *study drug* in this
consent, that is being studied for its ability to reduce blood clotting with
potentially fewer bleeding events. Abelacimab is an antibody (type of protein
made by the immune system) that binds to another protein that plays an
important role in blood clot formation.
The purpose of this study is to see if patients taking abelacimab have fewer
bleeding events compared to those taking apixaban. Apixaban is approved by
Health Authorities in The Netherlands to treat patients with an increased risk
of blood clots

This study has been transitioned to CTIS with ID 2023-509569-19-00 check the CTIS register for the current data.

The primary objective of this study is to assess whether abelacimab is
non-inferior to apixaban for preventing VTE recurrence at 6 months post
randomization in patients with cancer and recently diagnosed VTE. If
noninferiority is demonstrated, then superiority will be assessed.

This is a randomized, open-label, blinded endpoint evaluation (PROBE), active
controlled study.

1. Abelacimab 150 mg iv on Day 1 then, starting approximately 30 days later,
abelacimab 150 mg sc every month for an additional 5 months
(sc administration planned on Days 31, 61, 91, 121, and 151 ± 5 days).

2. Apixaban 10 mg bid for 7 days, followed by 5 mg bid for a total period of 6
months. If a patient receives apixaban at a dose of 10 mg bid
without interruption during screening and is randomized to the apixaban
treatment arm, the on-study treatment duration with the 10
mg bid dose will be shortened so that no patient receives more than 7 days of
the 10 mg bid dose of apixaban.

Side effects from study medication abelacimab and apixaban.

Injection site reaction

Risks associated with blood collection include pain, swelling and/or bruising
at the insertion site of the needle.

ECG - a patient may have a mild irritation, slight redness, or itching at the
sites on the skin where the recording patches are placed.

Abelacimab may help to effectively treat the clot in the body and help prevent
blood clots from forming again. However, there is no guarantee that there will
be any benefit to the subject.