NCT07059221招募中1 期
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
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- RP2D
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Subject with advanced or distant metastatic squamous cell carcinoma of the head and neck confirmed by histology or cytology.
- •At least one measurable lesion according to RECIST v1.1 criteria.
- •The ECOG score is 0 or
- •Expected survival ≥12 weeks.
- •Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.
排除标准
- •1. Subjects will not be screened if they meet any of the following conditions:
- •Primary tumor located in the nasopharynx, salivary glands, sinuses, skin, or squamous cell carcinoma of unknown primary origin;
- •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:
- •Use of any investigational drug within 4 weeks before the first dose;
- •Concurrent enrollment in another clinical trial, unless it is an observational (non-interventional) study or follow-up in an interventional study;
- •Active autoimmune disease or a history of autoimmune disorders.
- •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/exclusion criteria.
- •6. Uncontrolled or symptomatic active CNS metastases.
- •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.
- •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.
- •Active or chronic infections of clinical significance.
- •Pregnancy or lactation.
- •Other factors that, in the investigator's judgment, may lead to premature study discontinuation.
研究组 & 干预措施
SHR-A2102+Adebrelimab
Experimental
干预措施: Adebrelimab (Drug)
SHR-A2102+Adebrelimab+Cetuximab
Experimental
干预措施: Cetuximab (Drug)
SHR-A2102+Adebrelimab
Experimental
干预措施: SHR-A2102 (Drug)
SHR-A2102+Adebrelimab+Cetuximab
Experimental
干预措施: SHR-A2102 (Drug)
SHR-A2102+Adebrelimab+Cetuximab
Experimental
干预措施: Adebrelimab (Drug)
Adebrelimab+ SHR-9839(sc)+ Carboplatin / Cisplatin
Experimental
干预措施: SHR-9839(sc) (Drug)
Adebrelimab+ SHR-9839(sc)+ Carboplatin / Cisplatin
Experimental
干预措施: Carboplatin / Cisplatin (Drug)
SHR-9839(sc)
Experimental
干预措施: SHR-9839(sc) (Drug)
Adebrelimab+ SHR-9839(sc)+ Carboplatin / Cisplatin
Experimental
干预措施: Adebrelimab (Drug)
结局指标
主要结局
RP2D
时间窗: 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)
时间窗: 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
时间窗: 5 years after the last subject was enrolled in the group
efficacy was assessed every 6 weeks as determined by RECIST1.1
次要结局
- DCR(5 years after the last subject was enrolled in the group)
- DOR(5 years after the last subject was enrolled in the group)
- PFS(Investigator evaluation)(5 years after the last subject was enrolled in the group)
- OS(Investigator evaluation)(5 years after the last subject was enrolled in the group)
研究者
研究点 (2)
Loading locations...
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