Phase 1b of ASLAN001 (Varlitinib) in Patients With Advanced/ Metastatic Hepatocellular Carcinoma (HCC)

Summary

This is a single-arm, allocation open label study. Phase 1 is a dose-finding phase in patients with advanced/ metastatic hepatocellular carcinoma (HCC) who have progressed on first line Sorafenib or Lenvatinib. The primary objective of this study will be to establish the maximal tolerable dose (MTD) of ASLAN001 (Varlitinib) in the study population The secondary objectives include: 1. To evaluate the efficacy of ASLAN001 (Varlitinib), as measured by duration of response (DoR), progression free survival (PFS), overall survival (OS) and disease control rate (DCR) 2. To assess the ORR, DoR, PFS, DCR and OS by tumor EGFR/HER2/HER3/HER4 status 3. To identify tumor and host biomarkers predictive of treatment response or toxicity to ASLAN001.

Timeline

Start

2017-05-05

Primary completion

2019-05-05

Completion

2021-05-05

Publications

• Background Subbiah IM, Subbiah V, Tsimberidou AM, Naing A, Kaseb AO, Javle M, Fu S, Hong DS, Piha-Paul S, Wheler JJ, Hess KR, Janku F, Falchook GS, Wolff RA, Kurzrock R. Targeted therapy of advanced gallbladder cancer and cholangiocarcinoma with aggressive biology: eliciting early response signals from phase 1 trials. Oncotarget. 2013 Jan;4(1):156-65. doi: 10.18632/oncotarget.832.
• Background Yang X, Wang W, Wang C, Wang L, Yang M, Qi M, Su H, Sun X, Liu Z, Zhang J, Qin X, Han B. Characterization of EGFR family gene aberrations in cholangiocarcinoma. Oncol Rep. 2014 Aug;32(2):700-8. doi: 10.3892/or.2014.3261. Epub 2014 Jun 13.

Drugs

Indications