A Phase 2 study to investigate efficacy, safety and pharmacokinetics of BGB-A317 in patients with inoperable liver cancer

Phase 1

• Conditions: Previously Treated Unresectable Hepatocellular Carcinoma; MedDRA version: 21.0 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-003983-10-GB
• Lead Sponsor: BeiGene Ltd., c/o BeiGene USA, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-21
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 228

Inclusion Criteria

1. Histologically confirmed HCC
2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach
3. Has received at least 1 line of systemic therapy for unresectable HCC Measurable disease
4. Child-Pugh score A
5. Easter Cooperative Oncology Group (ECOG) Performance Status = 1
6. Adequate organ function
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 103

Exclusion Criteria

1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
2. Prior therapies targeting PD-1 or PD-L1
3. Has known brain or leptomeningeal metastasis
4. Tumor thrombus involving main trunk of portal vein or inferior vena cava
5. Loco-regional therapy to the liver within 4 weeks before enrollment
6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc
7. Has received:
a. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies
b. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer
8. Active autoimmune diseases or history of autoimmune diseases that may relapse.
9. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified