A Phase Ib/II Open-label, Multi-center Study of the Combination of MEK162 Plus AMG 479 (Ganitumab) in Adult Patients With Selected Advanced Solid Tumors

Inclusion Criteria:

- Patients aged ≥ 18 years

- Patients with advanced solid tumors (CRC, melanoma) with documented somatic KRAS or
BRAFV600 mutations in tumor tissue. Patients with metastatic pancreatic
adenocarcinoma may be enrolled irrespectively of KRAS or BRAFV600 mutational status.

- Patients must have relapsed or progressed following standard therapy or patients for
whom no standard anticancer therapy exists.

- Measurable disease as determined by RECIST v1.1. World Health Organization (WHO)
Performance Status (PS) ≤ 2.

- Adequate organ function

- Negative serum pregnancy test

Exclusion Criteria:

- Prior therapy with MEK- or IGF-1R- inhibitor

- History or current evidence of central serous retinopathy (CSR), retinal vein
occlusion (RVO) or retinal degenerative disease

- Patients with known history of severe infusion reactions to monoclonal antibodies

- Patients with primary CNS tumor or CNS tumor involvement

- History of thromboembolic event requiring full-dose anticoagulation therapy

- Clinically significant cardiac disease

- History of another malignancy within 2 years

- Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply