SHR-A2102
DrugAdministration by intravenous infusion
NCT Number: NCT07059221
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
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1 / Phase 2
Chongqing University Cancer Hospital, Chongqing, Chongqing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
Administration by intravenous infusion
Administration by intravenous infusion
Administration by intravenous infusion
Administration by Subcutaneous injection
Administration by intravenous infusion
Time frame: through phase IB completion, an average of 5 years
RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in Phase IB stages
Time frame: from Day1 to 90 days after last dose
According to NCI-CTCAE v5.0 evaluation criteria from Day 1 to 90 days after last dose
Time frame: 5 years after the last subject was enrolled in the group
efficacy was assessed every 6 weeks as determined by RECIST1.1
Time frame: 5 years after the last subject was enrolled in the group
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
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
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
Since C1D1 and death from any cause
Contact information is provided by the study sponsor or research team.
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Industry
A Multicenter, Open-label Phase Ib/II Clinical Trial of SHR-A2102 Injection in Combination With Adebrelimab Injection, With or Without Other Anti-tumor Therapies, in Subjects With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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