Overview
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Failed or Intolerance to Standard Therapy
Description
This study is an open-label phase II clinical study to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Failed or Intolerance to Standard Therapy. In this study, eligible subjects will be randomized at 1:1:1 ratio, and the patients will be administered with HLX43 at different doses via intravenous infusion.
Eligibility
Inclusion Criteria:
1. Volunteer to participate in clinical research;To fully understand and understand this study and to sign the Informed Consent Form (ICF);Willing to follow and able to complete all test procedures
2. The age of signing ICF is ≥ 18 years old and ≤ 75 years old，regardless of gender;
3. Hepatocellular carcinoma (HCC) confirmed by histopathology or cytology, or clinically meeting the American Association of Hepatology (AASLD) criteria for HCC diagnosis；
4. Previous failure or progression of at least one standard systemic therapy for hepatocellular carcinoma (standard therapy refers to PD-1/ L1-based combination therapy, or lenvatinib, sorafenib), or intolerability toxicity (CTCAE≥3 adverse events), or contraindications to standard therapy.
5. Barcelona Clinic Liver Cancer (BCLC) stage C; BCLC stage B patients who are not suitable for locoregional therapy may also be enrolled.
6. Within 4 weeks prior to the first administration of the medication, at least one measurable target lesion must be evaluated according to the RECIST v1.1 criteria. A region that has received prior local treatment may also be selected as a target lesion if there is a clear progression that meets the RECIST v1.1 standards；
7. Tumor tissue should be provided as much as possible for an evaluable PD-L1 expression result at Screening period；
8. Before the initial administration of the study drug, there should be at least a 3-week interval or 5 times the half-life of the last cytotoxic chemotherapy, immunotherapy, or biological therapy, whichever is shorter. There should be at least a 2-week interval from the previous small molecule targeted therapy, at least a 1-week interval from traditional Chinese medicine treatment with antitumor indications or minor surgery. Additionally, treatment-related adverse events (AEs) should have recovered to NCI-CTCAE grade ≤ 1 (except for grade 2 peripheral neurotoxicity and alopecia)；
9. Child-pugh liver function rating within 7 days before the first administration of the study drug : grade A；
10. The ECOG physical performance score of 0-1 in the week prior to randomization；
11. Expected survival ≥ 3 monthes；
12. Subjects of HBsAg (-) and HBcAb (-) are allowed to be enrolled. If HBsAg (+) or HBcAb (+), then HBV-DNA must be \< 500 IU/mL or \<2500 copy/ml or \
