Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Institute Of Biological Products
About this trial
This phase II study will be conducted in two parts (Ⅱa and Ⅱb), with a 21-day treatment cycle until disease progression, intolerable toxicity, withdrawal of informed consent, death, initiation of new anti-tumor treatment or loss of follow-up.
Eligibility criteria
Qualifiers
The subjects voluntarily participated in the study and signed the informed consent.
Male and female aged between 18 and 75 years old, regardless of gender.
Patients with recurrent/metastatic advanced HNSCC who have been diagnosed by histology or cytology, progressed or intolerant after previous immunotherapy containing anti-PD-1/anti-PD-L1 and platinum, and have no indication of radical local treatment. Subjects should not receive more than 2 lines of treatment in the past.
During the screening period, subjects must provide tumor tissues and blood samples for biomarker detection. If the subject does not have an archived tumor tissue sample, he or she will undergo a fresh tumor biopsy during the screening period to obtain the corresponding tumor sample. If the subject can't provide archived or fresh tumor tissue samples, but can provide the previous test reports of qualified institutions, including all biomarker indicators specified in this scheme, they can be screened after communicating with the sponsor.
Disqualifiers
The primary site of squamous cell carcinoma is nasal cavity, paranasal sinuses, nasopharynx and salivary gland.
The participant has received any HER3 targeting or EGFR targeting therapy in the past.
Active central nervous system metastasis and/or meningeal metastasis.
Previous allergy to human normal immunoglobulin or antibody preparation or other serious infusion reaction; Severe hypersensitivity disease, allergic constitution.
Trial design
Treatments tested in this trial
- HER3 Monoclonal antibodies-Dose A
- HER3 Monoclonal antibodies-Dose B
- HER3 Monoclonal antibodies-Dose C
- HER3 Monoclonal antibodies-Dose D
- Placebo
- Cetuximab injection
Treatment groups
81 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov