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A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard Therapy

ConditionCarcinoma, Hepatocellular
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Henlius Biotech

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibroblastic layer cell carcinoma are known;

History of any second malignant tumor within the first 2 years prior to randomization, excluding early-stage malignancies that have been treated curatively (carcinoma in situ or stage I tumors), such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, breast ductal carcinoma in situ, and papillary thyroid carcinoma;

History of hepatic encephalopathy or has undergone a liver transplant. Patients who are preparing for or have previously undergone organ or bone marrow transplantation;

Within 6 months prior to randomization, present with portal hypertension accompanied by upper gastrointestinal bleeding, or have esophageal/gastric varices with red wale markings, or are at risk of ruptured hemorrhagic hepatic cancer nodules, or are considered by the researcher to be at high risk of bleeding;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HLX43 DOSE 1

    Drug

    Dose 1; HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

  • HLX43 DOSE 2

    Drug

    Dose 2; HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

  • HLX43 DOSE 3

    Drug

    Dose 3; HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: HLX43 DOSE 1Experimental treatment 1 intervention
Group B: HLX43 DOSE 2Experimental treatment 1 intervention
Group C: HLX43 DOSE 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

Objective response rate (ORR) (assessed by INV according to the RECIST v1.1 criteria)

Time frame
up to 24 week
2

PFS

Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by INV according to the RECIST v1.1 criteria.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 14 months

Secondary outcomes

1

ORR

Objective response rate (ORR) (assessed by the IRRC according to the RECIST v1.1 criteria)

Time frame
up to 24 weeks
2

PFS

Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by the IRRC according to the RECIST v1.1 criteria.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 14 months
3

OS

Overall Survival

Time frame
From randomization to death from any cause (up to approximately 36 months)
4

Incidence and severity of adverse events (AEs)

severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version \[v\] 5.0, vital signs and clinical laboratory test results

Time frame
time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 months

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Hunan Cancer HospitalRecruiting410013, Hunan, HunanChinaChina

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Henlius Biotech

Lead sponsor

Source ClinicalTrials.gov
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