Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A2102+Adebrelimab | Experimental |
| |
| SHR-A2102+Adebrelimab+Cetuximab | Experimental |
| |
| SHR-9839(sc) | Experimental |
| |
| Adebrelimab+ SHR-9839(sc)+ Carboplatin / Cisplatin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A2102 | Drug | Administration by intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| RP2D | RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in Phase IB stages | 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 | from Day1 to 90 days after last dose |
| ORR | efficacy was assessed every 6 weeks as determined by RECIST1.1 | 5 years after the last subject was enrolled in the group |
| Measure | Description | Time Frame |
|---|---|---|
| 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; | 5 years after the last subject was enrolled in the group |
| DOR |
Not provided
Inclusion Criteria:
Exclusion Criteria:
-
1. Subjects will not be screened if they meet any of the following conditions:
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:
6. Uncontrolled or symptomatic active CNS metastases. 7. Symptomatic visceral metastases with imminent life-threatening complications .
8. Severe bone damage caused by tumor bone metastasis, including severe bone pain that is poorly controlled; pathological fractures in important areas that occurred within 6 months before the first medication or are expected to occur very soon; and spinal cord compression.
9. Known or suspected interstitial lung disease (ILD) or severe pulmonary conditions.
10. Other active malignancies within 3 years before study entry. 11. Have a history of immunodeficiency, including a positive HIV test result, or suffer from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation.
12. Clinically significant cardiovascular disease. 13. Active or chronic infections of clinical significance. 14. Pregnancy or lactation. 15. Other factors that, in the investigator's judgment, may lead to premature study discontinuation.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huijie Duan | Contact | +86 17721286337 | huijie.duan@hengrui.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing University Cancer Hospital | Recruiting | Chongqing | Chongqing Municipality | 400030 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Adebrelimab | Drug | Administration by intravenous infusion |
|
| Cetuximab | Drug | Administration by intravenous infusion |
|
| SHR-9839(sc) | Drug | Administration by Subcutaneous injection |
|
| Carboplatin / Cisplatin | Drug | Administration by intravenous infusion |
|
Since C1D1 every 6 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1;
| 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; | 5 years after the last subject was enrolled in the group |
| OS(Investigator evaluation) | Since C1D1 and death from any cause | 5 years after the last subject was enrolled in the group |
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided