Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer

Inclusion criteria:

- Males and females aged >=18 years (for Japan only: Age >=20 years at time of signing
Informed Consent Form) with histologically confirmed metastatic colorectal cancer
(mCRC).

- Metastatic disease not amenable to surgical curative treatment and eligible to receive
therapy with mFOLFOX6 (Leucovorin/5-Fluorouracil/Oxaliplatin) + bevacizumab.

- At least one measurable lesion according to Response Evaluation Criteria in Solid
Tumors (RECIST) 1.1.

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

- Adequate hepatic, renal and bone marrow function.

- Further inclusion criteria apply.

Exclusion criteria:

- Prior systemic therapy for metastatic disease

- Prior therapy with monoclonal antibodies or small molecule inhibitors against Vascular
endothelial growth factor (VEGF) or VEGF receptors, including Avastin® or Avastin®
biosimilar

- Previous malignancy other than Colorectal cancer (CRC) in the last 5 years except for
basal cell cancer of the skin or pre-invasive cancer of the cervix

- Spinal cord compression or brain metastases unless asymptomatic, stable and not
requiring steroids for at least 6 weeks prior to start of study treatment

- Any unresolved toxicity > Common Toxicity Criteria Grade 1 (except alopecia) from
previous anticancer therapy (including radiotherapy)

- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of
bleeding

- A thrombotic or hemorrhagic event <=6 months prior to screening (includes hemoptysis,
Gastrointestinal (GI) bleeding, hematemesis, central nervous system hemorrhage,
epistaxis, vaginal bleeding, cerebral infarction, transient ischemic attacks,
myocardial infarction, angina, and coronary artery disease)

- Further exclusion criteria apply