NCT04837508Unknown2 期
An Open-label, Single-arm, Multi-center, Phase II Clinical Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 86
- 试验地点
- 7
- 主要终点
- Objective Response Rate (ORR) by Independent Review Committee (IRC)
研究概览
简要总结
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 as single agent in HER2-positive unresectable locally advanced or metastatic biliary tract cancer patients who have progressed during or relapsed after at least one prior stand therapy.
详细描述
The study consists of two stages. In Phase IIa, 25-31 eligible subjects will be enrolled to evaluate the safety and preliminary efficacy of MRG002. Based on the initial safety and efficacy data obtained from the Phase IIa, the study design of the second stage Phase IIb single-arm study either will be adjusted or the trial will be stopped. If the Phase IIa data support the continuation of the study, in the second stage, approximately an additional 55 subjects will be enrolled to further evaluate the efficacy and safety of MRG002.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to sign the ICF and follow the requirements specified in the protocol.
- •Aged 18 to 75 (including 18 and 75), both genders.
- •Expected survival time ≥ 12 weeks.
- •Patients with unresectable locally advanced or metastatic biliary tract cancer confirmed by histopathology.
- •Failed in the prior one or more standard therapies.
- •HER2 positive (IHC 3 + or IHC 2 +) in the tumor specimens confirmed by central laboratory test.
- •Archival or biopsy tumor specimens should be provided (primary or metastatic).
- •Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- •ECOG performance score 0 or
- •Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤ Grade 1 (except alopecia, non-clinically significant or asymptomatic laboratory abnormalities).
- •No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%.
- •Organ function must meet the basic requirements.
- •Coagulation function must meet the basic requirements.
- •Patients of childbearing potential must take effective contraceptive measures during the treatment and for 6 months after the last dose of treatment.
排除标准
- •History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab.
- •Received chemotherapy, radiotherapy, biologicals, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first MRG002 treatment.
- •Presence of clinical manifestation of biliary obstruction.
- •Patients with clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage.
- •Presence of central nervous system (CNS) metastasis and/or neoplastic meningitis.
- •Any severe or uncontrolled systemic diseases.
- •Patients with poorly controlled heart diseases.
- •Evidence of active infections, including but not limited to Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection.
- •History of other primary malignancies.
- •History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
- •Peripheral neuropathy greater than Grade
- •History of cirrhosis (decompensated cirrhosis Child-Pugh class B and C).
- •Patients with active autoimmune disease or a history of autoimmune disease, who are using immunosuppressive agents, or systemic hormone therapy and still receiving within 2 weeks prior to enrollment.
- •Received anti-tumor vaccine treatment 4 weeks prior to the first dose or planning to participate in anti-tumor vaccine trials.
- •Female patents with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment.
- •Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.
研究组 & 干预措施
MRG002
Experimental
MRG002 will be administrated by an IV infusion of 2.6 mg/kg on Day 1 of every 3 weeks (21-day cycle).
干预措施: MRG002 (Drug)
结局指标
主要结局
Objective Response Rate (ORR) by Independent Review Committee (IRC)
时间窗: Baseline to study completion, up to 12 months
ORR is defined as the percentage of patients with a complete response (CR) and partial response (PR) as assessed by Independent Review Committee (IRC) according to RECIST v1.1.
次要结局
- ORR by Investigator(Baseline to study completion, up to 12 months)
- Duration of Response (DoR)(Baseline to study completion, up to 12 months)
- Time to Response (TTR)(Baseline to study completion, up to 12 months)
- Disease Control Rate (DCR)(Baseline to study completion, up to 12 months)
- Progression Free Survival (PFS)(Baseline to study completion, up to 12 months)
- Overall Survival (OS)(Baseline to study completion, up to 12 months)
- Adverse Events (AEs)(Baseline to 30 days after the last dose of study treatment)
- Pharmacokinetics (PK) Parameter of MRG002: concentration-time curve(Baseline to 30 days after the last dose of study treatment)
- Incidence of anti-drug antibody (ADA)(Baseline to 30 days after the last dose of study treatment)
研究者
研究点 (7)
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