SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.
About this trial
This is a Phase II study of anti-nectin-4 ADC combined with the EGFR monoclonal antibody and the PD-1 monoclonal antibody in participants with advanced head and neck squamous cell carcinoma.
Eligibility criteria
Qualifiers
Aged 18 years or older, regardless of gender.
Able to understand and voluntarily sign a written informed consent form (ICF).
Confirmed recurrent or metastatic HNSCC that is not curable with local treatments. Primary tumor must be located in the oral cavity, oropharynx, hypopharynx, or larynx.
Able to provide well-preserved or fresh tumor tissue.
Disqualifiers
Primary tumor located in the nasopharynx, nasal cavity, paranasal sinuses, salivary glands, thyroid or parathyroid glands, skin, or squamous cell carcinoma with an unknown primary site.
Presence of leptomeningeal metastasis, spinal cord compression, symptomatic or progressive brain metastases.
(Only for Stage 2 in Part 2) Prior systemic anti-tumor therapy for recurrent or metastatic HNSCC.
Known allergy to any component of SYS6002, JMT101, or Enlonstobart injection.
Trial design
Treatments tested in this trial
- JMT101
- SYS6002
- SG001
Treatment groups
430 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Locations
Sponsors and collaborators
Source ClinicalTrials.gov