A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor

Inclusion Criteria

• ≥ 18 years of age
• Adequate organ function
• Life expectancy ≥ 3 months
• Women of childbearing potential must have a negative serum pregnancy test
• Advanced/metastatic solid tumor (Phase 1b)
• Availability of tumor tissue at screening
• ECOG performance status of 0 to 1
• Measurable disease (RECIST v1.1) (Phase 2)
• Advanced, recurrent, or metastatic gynecological solid tumor (Phase 2)
• Willing and able to fast, and to eat a high-fat breakfast (Food Effect) General

Exclusion Criteria

• Prior treatment with lucitanib
• Active second malignancy
• Active central nervous system brain metastases
• Pre-existing duodenal stent or any gastrointestinal disorder
• Known history of HIV or AIDs; positive result of hepatitis B or C viruses
• Evidence of interstitial lung disease, active pneumonitis, myocarditis, or history of myocarditis
• Active, known or suspected autoimmune disease (eg, autoimmune hepatitis)
• Condition requiring systemic treatment with corticosteroids or other immune suppressive medications
• Unstable or uncontrolled hypertension (BP ≥ 140/90 mmHg)
• Prior treatment with a VEGFR-tyrosine kinase inhibitor (Phase 2)