NCT06474468招募中1 期
A Phase IB /II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer
适应症
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
- 148
- 试验地点
- 1
- 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 with Adebrelimab with or without other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer. To explore the reasonable dosage of SHR-A2102 for Advanced or Metastatic Esophageal Cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 70 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；
- •The age of signing the informed consent is 18 -70 years, regardless of gender；
- •Provide archived or fresh tumor tissue for vendor test;
- •At least one measurable lesion according to RECIST v1.1 criteria；
- •Subjects with pathology confirmed locally advanced unresectable or metastatic esophageal squamous cell carcinoma;
- •The ECOG score is 0 or 1；
- •Expected survival ≥12 weeks
- •Good level of organ function
- •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
- •Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases；
- •Patients with uncontrolled tumor-related pain as determined by the investigator.
- •Moderate or severe ascites with clinical symptoms (i.e., those who required therapeutic puncture or drainage within 2 weeks before the study treatment, and only those who showed a small amount of ascites without clinical symptoms could be included in the study); Unable to control or moderate or higher amounts of pleural effusion or pericardial effusion
- •A history of gastrointestinal perforation and/or fistula within 6 months prior to initial medication, or significant tumor invasion of adjacent organs (large arteries or trachea, etc.), resulting in a higher risk of bleeding or fistula
- •Have antitumor therapy was received 4 weeks before the start of the study；
- •Have previously received antiboy-coupled drugs containing topoisomerase I inhibitors
- •Systemic antitumor therapy was received 4 weeks before the start of the study
- •Treatment with CYP3A4, CYP2D6, P-gp, or BCRP booster or inducer is less than 5 drug half-lives from the date of first administration
- •Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, diagnostic or superficial surgery was performed within 7 days prior to the initial study, or elective surgery was expected during the trial period;
- •Perform non-chest radiation therapy with >30Gy within 28 days before dosing, chest radiation therapy with >30Gy within 24 weeks before first dosing, and radiation therapy with ≤30Gy within 14 days before first dosing
- •Toxicity and/or complications of previous antitumor therapy did not return to NCI-CTCAE level ≤1 or exclusion criteria
- •Live attenuated vaccines were used within 28 days prior to initial study administration or during the expected study treatment；
- •Systemic immunosuppressive therapy was administered within 14 days prior to the first study
- •Subjects with known or suspected interstitial pneumonia;
- •In the first study, a single blood loss ≥50ml or a cumulative daily blood loss ≥300m occurred within 1 month before medication
- •Subjects with severe cardiovascular and cerebrovascular disease;
- •Arterial/venous thrombosis events, such as deep vein thrombosis and pulmonary embolism, occurred within 3 months prior to initial administration
- •Had been diagnosed with any other malignancy
- •Subjects who had a severe infection within 28 days prior to the first dose
- •Active hepatitis B or active hepatitis C
- •Patients with active pulmonary tuberculosis within 1 year prior to enrolment
- •History of immune deficiency
- •Severe allergic reactions are known to occur in individuals allergic to any component of SHR-A2102, SHR-1316, or other monoclonal antibody/fusion protein drugs
- •Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.
研究组 & 干预措施
Treatment group A/B
Experimental
A：SHR-A2102+Adebrelimab B：SHR-A2102+Adebrelimab+Cisplatin
干预措施: SHR-A2102；Adebrelimab；Cisplatin (Drug)
结局指标
主要结局
RP2D
时间窗: through phase IB completion, an average of 1 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: 18 months after the last subject was enrolled in the group
efficacy was assessed every 6 weeks within 48 weeks and every 9 weeks after 48 weeks s as determined by RECIST1.1
次要结局
- OS(Investigator evaluation)(18 months after the last subject was enrolled in the group)
- PFS(Investigator evaluation)(18 months after the last subject was enrolled in the group)
- DCR(18 months after the last subject was enrolled in the group)
- DOR(18 months after the last subject was enrolled in the group)
研究者
研究点 (1)
Loading locations...
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