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OncoMatch/Clinical Trials/NCT06742892

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

Is NCT06742892 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including HLX43 DOSE 1 and HLX43 DOSE 2 for carcinoma, hepatocellular.

Phase 2RecruitingShanghai Henlius BiotechNCT06742892Data as of May 2026

Treatment: HLX43 DOSE 1 · HLX43 DOSE 2 · HLX43 DOSE 3The 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

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Biomarker criteria

Required: PD-L1 (CD274) expression (evaluable PD-L1 expression result at Screening period)

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

Disease stage

Required: Stage BCLC STAGE C, BCLC STAGE B (NOT SUITABLE FOR LOCOREGIONAL THERAPY) (BCLC)

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

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: systemic therapy (PD-1-based combination therapy, PD-L1-based combination therapy, lenvatinib, sorafenib)

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

Lab requirements

Blood counts

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)

Liver function

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

Child-pugh liver function rating within 7 days before the first administration of the study drug : grade A; Laboratory tests within the previous week confirm adequate organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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