NCT03507166已完成2 期
A Multicenter, Open Label，Single Arm，Phase II Study to Evaluate the Effect and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Objective Response Rate （ORR）
研究概览
简要总结
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with local advanced or metastatic HER2 positive endothelial 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary agreement to provide written informed consent.
- •Male or female, Age ≥ 18 years and < 80 years.
- •Predicted survival ≥ 12 weeks.
- •Have histologically or cytologically-confirmed diagnosis of inoperable, locally advanced or metastatic urothelial cancer of the bladder, renal pelvis, ureter.
- •Have had progression or intolerance following receipt of at least one systemic chemotherapy for advanced or metastatic disease.
- •Measurable disease according to RECIST 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •HER2-positive status confirmed by the central laboratory: IHC 2+ or 3+; Subject is able to provide specimens from primary or metastatic lesions for HER2 tests
- •Adequate organ function, evidenced by the following laboratory results:
- •Cardiac ejection fraction ≥ 50 %. Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5×109 /L Platelets ≥ 100×109 /L; Total bilirubin ≤ 1.5× ULN; Without liver metastasis: ALT and AST ≤ 2.5 x ULN; With liver metastasis: ALT and AST ≤ 5 x ULN; Serum creatinine ≤1.5×ULN or creatinine clearance (CrCl) ≥ 50 mL/min as calculated by the Cockcroft-Gault equation.
- •All female subjects will be considered to be of child-bearing potential unless they are postmenopausal, or have been sterilized surgically.Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception.
- •Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
排除标准
- •Known hypersensitivity to Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection.
- •History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment.
- •History of receiving Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection.
- •History of major surgery within 4 weeks of planned start of trial treatment.
- •Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
- •Currently known active infection with HIV or tuberculosis.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- •History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
- •known central nervous system metastases.
- •Pregnancy or lactation.
- •Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
研究组 & 干预措施
RC48-ADC
Experimental
Participants will receive RC48-ADC every 2 weeks (Q2W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
干预措施: RC48-ADC (Drug)
结局指标
主要结局
Objective Response Rate （ORR）
时间窗: up to 24 months
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
次要结局
- Disease control rate (DCR)(up to 24 months)
- ORR of HER2-positive patients(up to 24 months)
- Progression Free Survival (PFS)(up to 24 months)
- Duration of Response (DOR)(up to 24 months)
- Overall Survival(OS)(up to 24 months)
- Adverse Events(28 days after the last dose of study treatment)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
2 期
A Study of RC48-ADC in Subjects With HER2 Overexpressed Metastatic Biliary Tract CancerBiliary Tract CancerNCT04329429RemeGen Co., Ltd.57
已完成
2 期
A Study of RC48-ADC in Subjects With HER2-negative Locally Advanced or Metastatic Urothelial CancerUrothelial CarcinomaNCT04073602RemeGen Co., Ltd.19
已完成
2 期
A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2HER2 Overexpressing Gastric CarcinomaGastric CancerNCT03556345RemeGen Co., Ltd.127
招募中
2 期
A Study of RC48-ADC for the Treatment of HER2-expressing Gynecological MalignanciesGynecological MalignancyNCT04965519RemeGen Co., Ltd.120
尚未招募
2 期
RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive Non-muscle-invasive Bladder CancerNon-muscle Invasive Bladder CancerNCT05996952West China Hospital77