A Phase II Clinical Study to Evaluate HLX43 (Anti-PD-L1 ADC) in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Failed or Intolerance to Standard Therapy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

• The age of signing ICF is ≥ 18 years old and ≤ 75 years old,regardless of gender;

• Hepatocellular carcinoma (HCC) confirmed by histopathology or cytology, or clinically meeting the American Association of Hepatology (AASLD) criteria for HCC diagnosis;

• 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.

• Barcelona Clinic Liver Cancer (BCLC) stage C; BCLC stage B patients who are not suitable for locoregional therapy may also be enrolled.

• 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;

• Tumor tissue should be provided as much as possible for an evaluable PD-L1 expression result at Screening period;

• 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);

• Child-pugh liver function rating within 7 days before the first administration of the study drug : grade A;

⁃ The ECOG physical performance score of 0-1 in the week prior to randomization;

⁃ Expected survival ≥ 3 monthes;

⁃ 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 \<ULN to be eligible for enrollment. Subjects with negative HCV antibodies (-) or negative HCV-RNA are allowed to be included in the study. Subjects with negative HCV antibodies (-) or negative HCV-RNA are allowed to be included in the study. If HCV-RNA is positive, consent must be obtained to receive the local standard antiviral treatment, and participants must have ALT and AST levels ≤ 3×ULN to be eligible for enrollment. Subjects with co-infection of hepatitis B and hepatitis C need to be excluded (both HBV-DNA and HCV-RNA are positive);

⁃ Laboratory tests within the previous week confirm adequate organ function (within 14 days prior to the first dose of medication, without receiving interventions such as blood transfusions or granulocyte colony-stimulating factor);

⁃ Male and female subjects of childbearing potential must agree to use at least one highly effective method of contraception during the trial and for at least 6 months after the last dose of the study drug. Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.

Locations
Other Locations
China
Hunan Cancer Hospital
RECRUITING
Hunan
Contact Information
Primary
Hua Xiang, Dr.
2805566465@qq.com
0731-89762040
Backup
Shanzhi Gu, Dr
105575191@qq.com
0731-89762040
Time Frame
Start Date: 2025-03-03
Estimated Completion Date: 2027-06-05
Participants
Target number of participants: 90
Treatments
Experimental: HLX43 DOSE 1
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)
Experimental: HLX43 DOSE 2
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)
Experimental: HLX43 DOSE 3
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)
Related Therapeutic Areas
Sponsors
Leads: Shanghai Henlius Biotech

This content was sourced from clinicaltrials.gov