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 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 for n 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
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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. The age of signing the informed consent is \>= 18 years, regardless of gender. 3. Subject with advanced or distant metastatic squamous cell carcinoma of the head and neck confirmed by histology or cytology. 4. Tumors with primary foci located in the oropharynx, oral cavity, hypopharynx and larynx. 5. Provide archived or fresh tumor tissue for test. 6. At least one measurable lesion according to RECIST v1.1 criteria. 7. The ECOG score is 0 or 1. 8. Expected survival ≥12 weeks. 9. Good level of organ function. 10. 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; 3. Presence of necrotic lesions or significant tumor invasion into adjacent organs or blood vessels, as assessed by the investigator, posing a high risk of major bleeding. 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; 3. Last dose of anticancer therapy (including chemotherapy, biologic therapy, immunotherapy, targeted therapy, etc.) within 4 weeksbefore the first dose; for small-molecule targeted drugs, within 2 weeks or 5 half-lives (whichever is longer); traditional Chinese medicine with antitumor indications within 2 weeks before the first dose. 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； |
| OS(Investigator evaluation) | 5 years after the last subject was enrolled in the group | Since C1D1 and death from any cause |
| 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； |
Countries
China
Contacts
Primary ContactYifan Shen
Outcome results
None listed