NCT06155396招募中2 期
A Single-Arm, Open- Label, Multicenter Phase II Study of RC48-ADC in Combination With Zimberelimab Injection for the Treatment ,at Least First-line Platinum-containing Standard Therapy Failed in HER2-expressing Subject With Recurrent or Metastatic Cervical Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 12
- 主要终点
- Safety run-in ：Safety(adverse event)
研究概览
简要总结
This study will evaluate the efficacy,safety of RC48-ADC in Combination with Zimberelimab Injection for the Treatment ,at least first-line platinum-containing standard therapy failed in HER2-expressing subject with Recurrent or Metastatic Cervical Cancer
详细描述
This is a Phase II, Single-Arm ,multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC in Combination with Zimberelimab Injection for the Treatment ,at least first-line platinum-containing standard therapy failed in HER2-expressing subject with Recurrent or Metastatic Cervical Cancer.The HER2-expressing is defined as: the HER2 IHC 3+ or 2+, or 1+.subjects with IHC 2+ require testing for FISH.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •a)Patients with histologically confirmed HER2-expressing recurrent or metastatic cervical cancer who have failed at least 1 line of standard platinum-containing therapy ; b) Not suitable for surgery or radiotherapy;
- •Voluntarily agreed to participate in the study and signed an informed consent form.
- •Female, age ≥ 18 years
- •Expected survival ≥ 12 weeks
- •Central laboratory confirmation of HER2 expression: IHC 1+, 2+, or 3+; subjects with IHC 2+ require testing for FISH.
- •Central laboratory confirmation of PD-L1 expression
- •Measurable disease according to RECIST 1.1 standard
- •ECOG physical condition 0 or 1 point
- •Adequate organ function, criteria should be met during the screening period
- •ANC ≥1,500/µL
- •platelet count ≥100,000/μL
- •hemoglobin ≥9.0 g/dL
- •total bilirubin ≤1.5 × upper limit normal (ULN) OR direct bilirubin ≤ULN for subjects with total bilirubin >1.5 × ULN. Serum bilirubin ≤3× ULN for subjects with Gilbert's disease
- •CrCl ≥50 mL/min (measured by the Cockcroft-Gault formula as applicable, or 24-hour urine).
- •ALT and AST ≤2.5× ULN without liver metastases or ≤5× ULN with liver metastases
- •LVEF ≥>50%
- •Female subjects should be surgically sterilised, post-menopausal or agree to use at least one medically approved contraceptive method during and for 6 months after the end of the study treatment period, must have had a negative blood pregnancy test within 7 days prior to study entry, and must be non-lactating.
- •Willingness and ability to comply with trial and follow-up procedure arrangements.
排除标准
- •Have central nervous system metastases and/or carcinomatous meningitis.
- •Received anti-tumour therapy or participated in another clinical study treatment within 4 weeks prior to the start of study treatment.
- •Toxicity due to previous antineoplastic therapy has not recovered to NCI-CTCAE (version 5.0) grade 0-
- •Major surgery with incomplete recovery within 4 weeks prior to start of study dosing.
- •Serum virology examination (based on the normal value of the research center) :
- •HBsAg test results were positive, and HBV DNA copy number was positive;
- •HCVAb test results were positive (HCV RNA PCR test results were negative only to be included in this study);
- •HIVAb tested positive
- •Have received a live or live attenuated vaccine within 4 weeks prior to the start of study dosing; or plan to receive any vaccine during the study period
- •Grade 3 or higher heart failure
- •History of gastrointestinal perforation and/or fistula within the previous 6 months
- •Serious arterial/venous thrombotic event or cardiovascular accident within 1 year prior to study drug administration
- •Presence of active or progressive infection requiring systemic therapy, with severe infection within 4 weeks prior to first dose;
- •Presence of systemic disease not under stable control as judged by the investigator.
- •History of interstitial pneumonia, obstructive lung disease, drug-induced pneumonia, radiation pneumonia, idiopathic pneumonia or active pneumonia.
- •Clinically relevant pyelonephrosis cannot be alleviated by ureteral stents or percutaneous drainage.
- •Presence of active autoimmune disease requiring systemic therapy within 2 years prior to the start of study drug administration, allowing for relevant alternative therapy.
- •Other malignancy within 5 years prior to start of study drug administration.
- •Previous allogeneic haematopoietic stem cell transplantation.
- •Previous treatment with other Antibody-drug conjugateantibody-coupled drugs.
- •Known hypersensitivity to the drug vedicilizumab for injection and its components or to Zimberelimab injection and other monoclonal antibodies.
- •Have any other disease, metabolic abnormality, physical examination abnormality or laboratory test abnormality.
- •Estimated lack of patient adherence to participate in this clinical study.
研究组 & 干预措施
Disitamab Vedotin + Zimberelimab
Experimental
Disitamab Vedotin（RC48-ADC）with Zimberelimab arm
干预措施: Zimberelimab (Drug)
Disitamab Vedotin + Zimberelimab
Experimental
Disitamab Vedotin（RC48-ADC）with Zimberelimab arm
干预措施: Disitamab Vedotin (Drug)
结局指标
主要结局
Safety run-in ：Safety(adverse event)
时间窗: Up to approximately 2 years
to evaluate safety including adverse event rate and adverse event grade.
Dose extension period ：Objective Response Rate (ORR)
时间窗: Up to approximately 2 years
The objective response rate will be mainly analyzed by according to the RECIST 1.1 standard tumor evaluation by the investigator will be performed
次要结局
- Objective Response Rate(ORR)(Up to approximately 2 years)
- Duration of Response (DOR)(Up to approximately 2 years)
- Disease Control Rate(DCR)(Up to approximately 2 years)
- Progression-free survival (PFS), evaluated by the investigator(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
研究者
研究点 (12)
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