FGF401 in HCC and Solid Tumors Characterized by Positive FGFR4 and KLB Expression

Inclusion Criteria

• ECOG Performance Status ≤ 1
• Presence of at least one measurable lesion according to RECIST v1.1. c-i) FGF401 single agent-Phase I and Phase II, Group 3: Patients with HCC or advanced solid tumors, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists. c-ii) FGF401 single agent-Phase II, Groups 1 and 2: HCC patients previously treated with sorafenib for advanced HCC with documented disease progression during or after discontinuation of sorafenib treatment, or intolerance to sorafenib treatment c-iii) FGF401 in combination with PDR001:Advanced HCC patients who have received up to 2 previous lines of systemic treatment and one treatment must have included sorafenib with documented disease progression during or after discontinuation of sorafenib treatment, or intolerance to sorafenib treatment

Exclusion Criteria

• Previous treatment with a selective FGF19-FGFR4 targeted therapy and/or pan-FGFR inhibitor.
• Symptomatic CNS metastases which are neurologically unstable or requiring increasing doses of steroids to control their CNS disease.
• Patient having out of range laboratory values defined as:
• Hematology Hemoglobin ≤ 9 g/dL (SI Units: 90 g/L) Platelet count 3 x ULN Serum creatinine > 1.5 x ULN and/or creatinine clearance ≤ 45 mL/min
• Coagulation: PT > 4 seconds more than ULN or INR > 1.7
• Pregnant or nursing (lactating) women.

Other protocol-defined Inclusion/Exclusion criteria may apply.