The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102/SHR-9839(sc) with Adebrelimab with or without other Antitumor Therapy in Subjects with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.
To explore the reasonable dosage of SHR-A2102/SHR-9839（sc） for Subjects with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements.
Subject with advanced or distant metastatic squamous cell carcinoma of the head and neck confirmed by histology or cytology.
At least one measurable lesion according to RECIST v1.1 criteria.
The ECOG score is 0 or 1.
Primary tumor located in the nasopharynx, salivary glands, sinuses, skin, or squamous cell carcinoma of unknown primary origin;
Locally advanced patients who are candidates for curative surgery or local therapy and have the intention to undergo such treatment;
Use of any investigational drug within 4 weeks before the first dose;
Concurrent enrollment in another clinical trial, unless it is an observational (non-interventional) study or follow-up in an interventional study; 4. Active autoimmune disease or a history of autoimmune disorders. 5. Residual toxicity from prior anticancer therapy not resolved to ≤Grade 1 (CTCAE v5.0) (except for non-safety risks, such as alopecia) or not meeting the inclusion/exclusion criteria.
Single group
SHR-A2102
DrugAdministration by intravenous infusion
Adebrelimab
DrugAdministration by intravenous infusion
Cetuximab
DrugAdministration by intravenous infusion
SHR-9839(sc)
DrugAdministration by Subcutaneous injection
Carboplatin / Cisplatin
DrugAdministration by intravenous infusion
RP2D
RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in Phase IB stages
Incidence and severity of AE(DLT)
According to NCI-CTCAE v5.0 evaluation criteria from Day 1 to 90 days after last dose
ORR
efficacy was assessed every 6 weeks as determined by RECIST1.1
DCR
Since C1D1 every 6 weeks w and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；
DOR
Since C1D1 every 6 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；
PFS(Investigator evaluation)
Since C1D1 every 6 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；
OS(Investigator evaluation)
Since C1D1 and death from any cause
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