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HLX43 in Recurrent/Metastatic Gynecological Malignant Tumors
NCT06769152Phase 2
Key facts
- Status
- Recruiting
- Start
- Feb 2025
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- Henlius
- Modality
- Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Small Molecules
- Drugs
- HLX43
- Conditions
- Cervical Cancer (CC)ovarian cancer
01
Overview
Phase 2, randomised, open-label trial of HLX43 in Cervical Cancer (CC) and ovarian cancer (4 arms), sponsored by Henlius. Primary endpoints: Objective Response Rate at 24 weeks and Progression-Free Survival at 14 months. Started Feb 2025; status: recruiting.
02
Design
4 arms- Study design
- RandomizedOpen-label
HLX43 2.0mg/kg
HLX43 2.0mg/kg every 3 weeks (Q3W)
HLX43 2.5mg/kg
HLX43 2.5mg/kg every 3 weeks (Q3W)
HLX43 3.0mg/kg
HLX43 3.0mg/kg every 3 weeks (Q3W)
HLX43 3.0mg/kg loading dose
HLX43 3.0mg/kg loading dose every 3 weeks (Q3W)
03
Who it enrols
Patients aged 18-75 with recurrent/metastatic cervical or ovarian cancer who failed or are intolerant to standard first-line therapy, with ECOG 0-1, adequate organ function, and no prior topoisomerase I inhibitor ADCs.
04
Endpoints
Primary
Objective Response Rate
Progression-Free Survival
Secondary
Objective Response Rate
Progression-Free Survival
Overall Survival
Adverse Events
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