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

Completed · Phase 1/Phase 2

Conditions studied: Hepatocellular Carcinoma (HCC), Solid Malignancies

In brief

Estimate the maximum tolerated dose and/or recommended phase II dose and efficacy of FGF401 as single agent and in combination with PDR001 in patients with hepatocellular carcinoma and as single agent in patients with other solid malignancies based on RECIST 1.1.

Key facts

Study ID

NCT02325739

Run by

Novartis Pharmaceuticals

People needed

172

Starts

2014-12-29

Expected to finish

2019-05-30

Last updated by the study team

2024-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 < 75000/mm3 Absolute neutrophil count (ANC) < 1500/mm3
• Chemistry Total bilirubin ≥ 2 mg/dL AST and/or ALT > 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.

Where it is running

• University of California LA Santa Monica Location — Los Angeles, California, United States
• Massachusetts General Hospital Oncology Dept — Boston, Massachusetts, United States
• Uni Of TX MD Anderson Cancer Cntr — Houston, Texas, United States
• Novartis Investigative Site — Shanghai, Shanghai Municipality, China
• Novartis Investigative Site — Rennes, Ille Et Vilaine, France
• Novartis Investigative Site — Lille, France
• Novartis Investigative Site — Montpellier, France
• Novartis Investigative Site — Pessac, France
• Novartis Investigative Site — Toulouse, France
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Hanover, Germany
• Novartis Investigative Site — Heidelberg, Germany
• Novartis Investigative Site — Würzburg, Germany
• Novartis Investigative Site — Hong Kong, Hong Kong
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Modena, MO, Italy
• Novartis Investigative Site — Ōsaka-sayama, Osaka, Japan
• Novartis Investigative Site — Chuo Ku, Tokyo, Japan
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Seoul, South Korea
• Novartis Investigative Site — Seoul, South Korea
• Novartis Investigative Site — Seoul, South Korea
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Madrid, Spain

Full record on ClinicalTrials.gov

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