About this trial
The 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 Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Eligibility criteria
Qualifiers
Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;
Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;
Cohort 1: Patients with histologically confirmed recurrent/metastatic head and neck squamous cell carcinoma who have been refractory to previous systemic treatment;
Have not received systemic anti-tumor therapy for HNSCC in the recurrent or metastatic setting.
Disqualifiers
Patients with head and neck tumor who are indicated for locoregional radical treatment;
Patients with primary nasopharyngeal carcinoma;
Imaging examination shows that the tumor has invaded or surrounded the large blood vessels of the chest, neck, and pharynx, and there is imaging evidence that entering the study will induce risks of hemorrhage;
History of any second malignancy within 2 years prior to randomization, ;
Trial design
Treatments tested in this trial
- HLX43 DOSE 1
- HLX43 DOSE 2
- HLX43 DOSE 3
- HLX43 DOSE 2 + HLX10
- HLX43 DOSE 3 + HLX10
- HLX43 DOSE 2 + HLX10 + HLX07
- HLX43 DOSE 3 + HLX10 + HLX07
Treatment groups
7
Treatment groupsSee each treatment group below.