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NCT03499626

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

Status unknown Phase 1, PHASE2 Last updated 17 April 2018
What this trial tests

Phase 1, PHASE2 trial testing ASLAN001 in Advanced/ Metastatic Hepatocellular Carcinoma in 22 participants. Status unknown.

Timeline
5 May 2017
Primary endpoint
5 May 2019
5 May 2021

Quick facts

Lead sponsorNational University Hospital, Singapore
PhasePhase 1, PHASE2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment22
Start date5 May 2017
Primary completion5 May 2019
Estimated completion5 May 2021
Sites1 location across Singapore

Drugs / interventions tested

Conditions studied

Sponsor

National University Hospital, Singapore

Who can join

Adults 21 to 99, any sex, with Advanced/ Metastatic Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Epidermal Growth Factor Receptor Family and its Role in Gastric Cancer.
    Arienti C, Pignatta S, Tesei A. · · 2019 · cited 97× · PMID 31850207 · DOI 10.3389/fonc.2019.01308
  2. Tyrosine Kinase Receptors in Oncology.
    Esteban-Villarrubia J, Soto-Castillo JJ, Pozas J, San Román-Gil M, et al · · 2020 · cited 72× · PMID 33198314 · DOI 10.3390/ijms21228529
  3. Cell Surface Proteins in Hepatocellular Carcinoma: From Bench to Bedside.
    Siracusano G, Tagliamonte M, Buonaguro L, Lopalco L. · · 2020 · cited 8× · PMID 31991677 · DOI 10.3390/vaccines8010041
  4. Resistance to Antiangiogenic Therapy in Hepatocellular Carcinoma: From Molecular Mechanisms to Clinical Impact.
    Federico P, Giunta EF, Tufo A, Tovoli F, et al · · 2022 · cited 5× · PMID 36551730 · DOI 10.3390/cancers14246245
  5. Predictive value of biomarkers for lenvatinib in hepatocellular carcinoma.
    Hao X, Li Z, Su X, Li J, et al · · 2025 · PMID 40851753 · DOI 10.1177/17588359251363102

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Other trials of ASLAN001

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Data sources for this page

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