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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
Administration by intravenous infusion
Administration by intravenous infusion
Administration by intravenous infusion
Administration by Subcutaneous injection
Administration by intravenous infusion
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGWest China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGRP2D
RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in Phase IB stages
Time frame: through phase IB completion, an average of 5 years
Incidence and severity of AE(DLT)
According to NCI-CTCAE v5.0 evaluation criteria from Day 1 to 90 days after last dose
Time frame: from Day1 to 90 days after last dose
ORR
efficacy was assessed every 6 weeks as determined by RECIST1.1
Time frame: 5 years after the last subject was enrolled in the group
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;
Time frame: 5 years after the last subject was enrolled in the group
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;
Time frame: 5 years after the last subject was enrolled in the group
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;
Time frame: 5 years after the last subject was enrolled in the group
OS(Investigator evaluation)
Since C1D1 and death from any cause
Time frame: 5 years after the last subject was enrolled in the group
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