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A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy

StatusRecruiting
PhasePhase 2
Started2025-01-26
View on ClinicalTrials.gov ↗

Amendment history

2026-05-14
Study Status, Study Design, Arms and Interventions v3
Enrollment increased: 72 → 102 participants
Trial arms changed: 3 → 4
InterventionsHLX43 DOSE 1 (Drug), HLX43 DOSE 2 (Drug), HLX43 DOSE 3 (Drug)→HLX43 (Drug)
2026-01-12
Study Status, Study Design, Eligibility v2
Enrollment target60→72
Eligibility criteria+574 characters
[...] l Carcinoma (ESCC) confirmed by histopathology or cytology; PreviousPatients failurewith advanced esophageal squamous cell carcinoma who have failed or progressionare 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 th [...] of atCTCAE leastgrade one standard systemic therapy for cervical cancer, or intolerability toxicity (CTCAE≥3 adverse events).; Within 4 [...] [...]
2025-02-06
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-02-14→confirmed 2025-01-26
Study sites0→1
2025-01-09
Original filing
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.
Trial Details
NCT Number NCT06769113
Lead Sponsor Shanghai Henlius Biotech
Conditions Esophageal Cancer
Enrollment 102 participants
Start Date 2025-01-26
Primary Completion 2026-10-31 (estimated)
Study Completion 2027-06-05 (estimated)
Updated on ClinicalTrials.gov 2026-05-18