NCT04073602已完成2 期
An Open-label, Single-arm, Single-center, Phase II Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in Subjects With HER2-negative 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
- 19
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)as assessed by Investigator
研究概览
简要总结
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with locally advanced or metastatic HER2-negative urothelial 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.
- •Predicted survival ≥ 12 weeks.
- •Diagnosed with histologically or cytologically-confirmed locally advanced or metastatic urothelial cancer, originate from bladder, renal pelvis, ureter and urinary tract.
- •Unresectable or disease progression (i.e. locally advanced/metastasis) after surgery and at least regular chemotherapy including gemcitabine, cisplatin AND paclitaxel. Disease progression within 6 months of the completion of neo-adjuvant and adjuvant chemotherapy with gemcitabine, cisplatin AND paclitaxel is also eligible.
- •Measurable lesion according to RECIST 1.
- •HER2 negative (i.e. IHC -or 1+) as confirmed by the department of Pathology in Beijing Cancer Hospital. Subject is able to provide specimens from primary or metastatic lesions for HER2 tests.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment:
- •Cardiac ejection fraction ≥ 50 %. Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5×10^9/L Platelets ≥ 100×10^9/L; Total bilirubin ≤ 1.5× ULN; AST and ALT ≤ 2.5×ULN and ≤ 5 x ULN with hepatic metastasis; Serum creatinine ≤1.5×ULN.
- •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 the components of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate.
- •Toxicity of previous anti-tumor treatment not recovered to CTCAE Grade 0-1 (with exception of Grade 2 alopecia).
- •Pleural or abdominal effusion with clinical symptoms that requires ongoing treatment.
- •History of receiving any anti-cancer drug/biologic treatment within 3 weeks prior to trial treatment.
- •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.
- •Diagnosed with HBsAg , HBcAb positive and HBV DNA copy positive, or HCVAb positive.
- •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 3 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.
- •Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD;
- •Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment.
- •NYHA Class III heart failure
- •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 be treated with RC48-ADC 2.0 mg/kg, once every 2 weeks (Q2W) until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's 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)as assessed by Investigator
时间窗: 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
- Progression Free Survival (PFS)(24 months)
- Disease control rate (DCR)(24 months)
- Adverse Events(28 days after the last dose of study treatment)
- Duration of Objective Response (DOR)(24 months)
- Overall Survival(OS)(up to 24 months)
研究者
研究点 (1)
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