OncoMatch/Clinical Trials/NCT06769113
A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy
Is NCT06769113 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including HLX43 DOSE 1 and HLX43 DOSE 2 for esophageal cancer.
Treatment: HLX43 DOSE 1 · HLX43 DOSE 2 · HLX43 DOSE 3 — The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Recurrent/Metastatic Esophageal Squamous Cell Carcinomar (ESCC) Failed or Intolerance to Standard First-Line Therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression testing required
Tumor tissue should be provided as much as possible for an evaluable PD-L1 expression result at Screening period
Allowed: PD-L1 (CD274) expression positive (CPS ≥1)
for patients with PD-L1 expression positive [CPS ≥1], first-line standard therapy is defined as platinum-based chemotherapy and immune checkpoint inhibitor [ICI] therapy
Allowed: PD-L1 (CD274) expression negative (CPS <1)
for patients with PD-L1 expression negative [CPS <1], first-line standard therapy is defined as platinum-based chemotherapy
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — first-line
failed or are intolerant to prior first-line standard therapy (for patients with PD-L1 expression positive [CPS ≥1], first-line standard therapy is defined as platinum-based chemotherapy and immune checkpoint inhibitor [ICI] therapy; for patients with PD-L1 expression negative [CPS <1], first-line standard therapy is defined as platinum-based chemotherapy)
Cannot have received: antibody-drug conjugate (topoisomerase I inhibitor payload)
previous treatment with antibody-drug conjugates (ADCs) using a topoisomerase I inhibitor as the payload
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, granulocyte colony-stimulating factor, or recombinant human thrombopoietin)
Kidney function
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, granulocyte colony-stimulating factor, or recombinant human thrombopoietin)
Liver function
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, granulocyte colony-stimulating factor, or recombinant human thrombopoietin)
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, granulocyte colony-stimulating factor, or recombinant human thrombopoietin)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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