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A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors

StatusRecruiting
PhasePhase 2
Started2025-02-20
View on ClinicalTrials.gov ↗

Amendment history

2026-04-17
Study Status, Study Design, Arms and Interventions v4
Primary completion date2026-10-31→2026-12-31
Enrollment target130→190
Study arms3→4
InterventionsHLX43 DOSE 1 (Drug), HLX43 DOSE 2 (Drug), HLX43 DOSE 3 (Drug)→HLX43 (Drug)
2025-11-29
Study Identification, Study Status, Oversight, Study Description, Conditions, Study Design, Eligibility v3
Enrollment target60→130
Eligibility criteria+1,501 characters
[...] he age of signing ICF is ≥ 18 years old and ≤ 75 years old; CervicalCohort 1: Metastatic or recurrent cervical cancer (CC)including squamous cell, adenocarcinoma or adenosquamous histology confirmed by histopathology or cytology;. Cohort 2: Histologically confirmed high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. Cohort 1: Previous failure or progression of at least one standard systemic therapy for cervical cancer (For patients with PD-L1 expression positive [CPS≥1], the standard therapy is defined as platinum-based chemotherapy in combination with immune checkpoint in [...] [...]
Study description+6 characters
[...] icacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patientspatients with Recurrentrecurrent/Metastaticmetastatic Cervical Cancer (CC) Failedcervical or Intoleranceovarian cancer failed or intolerance to Standardstandard Firstfirst-Lineline Therapytherapy. In this study, eligible subjects will be randomized at 1:1 [...]
Study title+18 characters
A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Recurrent/MetastaticAdvanced CCGynecological FailedMalignant or Intolerance to Standard TherapyTumors
2025-03-03
Study Identification, Study Status, Contacts/Locations v2
Study sitescontacts updated at 1 of 1 site
Study titlerevised
A Phase II Clinical Study to Evaluate HLX43 in Patients withWith Recurrent/Metastatic CC Failed or Intolerance to Standard Therapy
2025-02-24
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2025-02-14→2025-02-20
Study sites0→1
Study titlerevised
A Phase II Clinical Study to Evaluate HLX43 in Patients Withwith Recurrent/Metastatic CC Failed or Intolerance to Standard Therapy
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 cervical cancer or ovarian cancer failed or intolerance to standard first-line therapy.
Trial Details
NCT Number NCT06769152
Lead Sponsor Shanghai Henlius Biotech
Conditions Cervical Cancer, Ovarian Cancer
Enrollment 190 participants
Start Date 2025-02-20
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-06-05 (estimated)
Updated on ClinicalTrials.gov 2026-04-22