drugset / Trial / NCT02325739
FGF401 in HCC and Solid Tumors Characterized by Positive FGFR4 and KLB Expression
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2014-12-29
- Primary completion
- 2019-05-30
- Completion
- 2019-05-30
Publications
- Chan SL, Schuler M, Kang YK, Yen CJ, Edeline J, Choo SP, Lin CC, Okusaka T, Weiss KH, Macarulla T, Cattan S, Blanc JF, Lee KH, Maur M, Pant S, Kudo M, Assenat E, Zhu AX, Yau T, Lim HY, Bruix J, Geier A, Guillen-Ponce C, Fasolo A, Finn RS, Fan J, Vogel A, Qin S, Riester M, Katsanou V, Chaudhari M, Kakizume T, Gu Y, Porta DG, Myers A, Delord JP. A first-in-human phase 1/2 study of FGF401 and combination of FGF401 with spartalizumab in patients with hepatocellular carcinoma or biomarker-selected solid tumors. J Exp Clin Cancer Res. 2022 Jun 2;41(1):189. doi: 10.1186/s13046-022-02383-5.
- Castanon Alvarez E, Giallombardo M, Gil-Bazo I, Papadimitriou K, Pauwels P, Peeters M, Rolfo C. Looking into the "Garden of the Hesperides": new drugs for hepatocellular carcinoma. Minerva Chir. 2015 Apr;70(2):119-29. Epub 2015 Jan 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FGF401 | Small molecule | 50 mg | Oral |
| Subject | FGF401 | Small molecule | 80 mg | Oral |
| Subject | FGF401 | Small molecule | 120 mg | Oral |
| Subject | FGF401 | Small molecule | 150 mg | Oral |
| Subject | Spartalizumab | Monoclonal antibody | 300 mg | Intravenous |