Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Conditions
Brief summary
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
Interventions
DRUGSHR-A2102
Administration by intravenous infusion
DRUGAdebrelimab
Administration by intravenous infusion
DRUGCetuximab
Administration by intravenous infusion
DRUGSHR-9839(sc)
Administration by Subcutaneous injection
Administration by intravenous infusion
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Subject with advanced or distant metastatic squamous cell carcinoma of the head and neck confirmed by histology or cytology. 3. At least one measurable lesion according to RECIST v1.1 criteria. 4. The ECOG score is 0 or 1. 5. Expected survival ≥12 weeks. 6. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.
Exclusion criteria
\- 1\. Subjects will not be screened if they meet any of the following conditions: 1. Primary tumor located in the nasopharynx, salivary glands, sinuses, skin, or squamous cell carcinoma of unknown primary origin; 2. Locally advanced patients who are candidates for curative surgery or local therapy and have the intention to undergo such treatment; 2\. Known hypersensitivity to the investigational drug or any of its excipients, or a history of severe allergic reactions to other monoclonal antibodies. 3\. Prior treatments or medications before the first dose of the study drug: 1. Use of any investigational drug within 4 weeks before the first dose; 2. 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RP2D | 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 |
| Incidence and severity of AE(DLT) | 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 |
| ORR | 5 years after the last subject was enrolled in the group | efficacy was assessed every 6 weeks as determined by RECIST1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR | 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； |
| DOR | 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； |
| PFS(Investigator evaluation) | 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； |
| OS(Investigator evaluation) | 5 years after the last subject was enrolled in the group | Since C1D1 and death from any cause |
Countries
China
Contacts
CONTACTHuijie Duan
Outcome results
None listed