Phase 1b of ASLAN001 (Varlitinib) in Patients With Advanced/ Metastatic Hepatocellular Carcinoma (HCC)
Status:
Unknown status
Trial end date:
2021-05-05
Target enrollment:
Participant gender:
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.