SYS6010 vs Investigator's Choice of Monotherapy in Patients With Recurrent or Metastatic HNSCC
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.
About this trial
This study is a randomized, controlled, open-label, multicenter phase III clinical trial, which aims to evaluate the efficacy, safety of SYS6010 compared with monotherapy in participants with HNSCC.
Eligibility criteria
Qualifiers
Participantss aged 18-75 years (inclusive);
Patients with pathologically confirmed head and neck squamous cell carcinoma (HNSCC);.
Participants have failed of platinum-based chemotherapy and PD-(L)1 inhibitors; for participants who received platinum-based chemotherapy and PD-(L)1 inhibitors in the adjuvant/neoadjuvant setting, disease recurrence or progression must have occurred within 6 months after completion of that therapy; radiographically confirmed disease progression during or after the most recent treatment regimen;
Participants must have measurable disease according to RECIST (version 1.1);
Disqualifiers
Pathologically confirmed patients with adenocarcinoma or sarcomatoid carcinoma etc.;
Active central nervous system metastases or leptomeningeal metastasis;
History of another malignancy within 3 years prior to randomization
Allergy to any component of SYS6010 or to humanized monoclonal antibodies，or to the control drugs (docetaxel, methotrexate, paclitaxel, cetuximab);
Trial design
Treatments tested in this trial
- SYS6010
- Investigator's Choice of monotherapy
Treatment groups
340 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov