2026-03-03
minor
Study Status, Oversight, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Primary completion date2027-10-30→2027-12-30
Completion date2028-07-15→2029-01-30
Enrollment target90→167
Study arms3→7
InterventionsHLX43 DOSE 1 (Drug), HLX43 DOSE 2 (Drug), HLX43 DOSE 3 (Drug)→HLX43 DOSE 1 (Drug), HLX43 DOSE 2 (Drug), HLX43 DOSE 2 + HLX10 (Drug), HLX43 DOSE 2 + HLX10 + HLX07 (Drug), HLX43 DOSE 3 (Drug), HLX43 DOSE…
Eligibility criteria+819 characters
[...] ≤ 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 failedbeen refractory to previous systemic treatment;
Cohort 2： Patients with histologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), including primary oropharyngeal, oral cavity, hypopharyngeal, or laryngeal carcinoma.
Previous treatment must meet the following requirements:
Have not received systemic anti-tumor th [...] At least one measurable lesion as per RECIST 1.1 within 4 weeks prior [...] [...]
Secondary endpoints4 to 2 entries
ORR
PFS
2025-06-09
minor
Study Identification, Study Status, Conditions, Contacts/Locations v1
Start dateestimated 2025-04-21→confirmed 2025-04-22
Study sites1→2
Study titlerevised
A Phase II Clinical Study to Evaluate HLX43 in Subjects withWith Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma