NCT04868162已完成2 期
An Open-Label, Single Arm, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck.
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
- 70
- 试验地点
- 2
- 主要终点
- Objective Response Rate (ORR) by Investigator per RECIST v1.1
研究概览
简要总结
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 and the combination of MRG003 and HX008 in patients with recurrent or metastatic squamous cell carcinoma of head and neck.
详细描述
The study consists of two stages. In Part A, approximately 60 patients will be enrolled to evaluate the safety and preliminarily efficacy of MRG003 at 2.0 and 2.3 mg/kg, to further explore the optimized dose. In Part B, 30 to 50 patients will be enrolled to evaluate the safety and preliminary efficacy of the combination of MRG003 and HX008.
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.
- •Expected survival time≥3 months.
- •Patients with histologically confirmed unresectable recurrent or metastatic squamous cell carcinoma of head and neck.
- •Failed prior platinum and/or anti-PD-1 treatment (Part A); failed or intolerant to at least one prior line of standard therapy (platinum-based regimen) (Part B)
- •Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- •ECOG performance score 0 or
- •Organ functions and coagulation function must meet the basic requirements.
- •Serum or urine pregnancy test negative within 7 days before the first dose of investigational drug.
- •Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.
排除标准
- •History of 4 or more systemic anti-tumor therapies for the recurrent or metastatic squamous cell carcinoma of head and neck.
- •≥Grade 2 peripheral neuropathy
- •Prior anti-tumor therapy with MMAE/MMAF ADCs
- •Expected surgery or any other form of systemic or local anti-tumor therapy.
- •History of systemic chemotherapy within 3 weeks before the first administration of the investigational drug, targeted small molecule therapy within 2 weeks or 5 half-life periods before the first administration (whichever is shorter), antitumor biological therapy or immunotherapy within 4 weeks before the first administration, or major surgery.
- •Known active CNS metastasis and/or cancerous meningitis.
- •Residual toxicity reactions caused by previous anti-tumor treatment or abnormal values of laboratory tests higher than grade 1 (CTCAE v5.0). Prior Grade 3 to 4 immune-related AE (irAE) or ≥Grade 2 heart-related irAE.
- •Uncontrolled or poorly controlled heart disease.
- •History of pulmonary embolism or deep vein thrombosis within 3 months before the first administration of the investigational drug.
- •Known history of malignancy.
- •History of severe dermatosis.
- •Uncontrolled or poorly controlled hypertension.
- •Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy.
- •Known allergic reaction to any ingredients or excipients of investigational drugs.
- •Known active hepatitis B or C.
- •Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or solid organ transplantation.
- •Active bacterial, viral, fungal, rickettsia, or parasitic infections that require systemic anti-infective treatment.
- •Vaccination of live virus vaccine within 30 days before the first administration of the study drug. Inactivated seasonal influenza vaccine or approved COVID-19 vaccine is allowed.
- •History of previous or concurrent interstitial pneumonia, radiation pneumonitis, severe chronic obstructive pulmonary disease, severe pulmonary dysfunction, symptomatic bronchospasm, etc.
- •Patients receiving immunology-based treatment for any reason.
- •Uncontrolled pleural effusion, pericardial effusion or recurrent ascites.
- •Potent CYP3A4 inhibitors or inducers are in use and cannot be discontinued.
- •Women who are lactating or pregnant.
- •Other conditions that in the clinical judgement of the investigator make the patient not suitable for participation in this study.
研究组 & 干预措施
Experimental Arm
Experimental
MRG003 monotherapy will be administered for patients enrolled into Part A of this study; MRG003 and HX008 combination will be administered for patients enrolled into Part B of this study.
干预措施: MRG003 (Drug)
Experimental Arm
Experimental
MRG003 monotherapy will be administered for patients enrolled into Part A of this study; MRG003 and HX008 combination will be administered for patients enrolled into Part B of this study.
干预措施: MRG003+HX008 (Drug)
结局指标
主要结局
Objective Response Rate (ORR) by Investigator per RECIST v1.1
时间窗: Baseline to study completion (up to 24 months)
ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1.
次要结局
- Overall Survival (OS)(Baseline to study completion (up to 24 months))
- Disease Control Rate (DCR)(Baseline to study completion (up to 24 months))
- Incidence of anti-drug antibody (ADA)(Baseline to 30 days after the last dose of study treatment)
- Duration of Response (DoR)(Baseline to study completion (up to 24 months))
- Progression Free Survival (PFS) as assessed by investigator(Baseline to study completion (up to 24 months))
- Adverse Events (AEs)(Baseline to 30 days after the last dose of study treatment)
- AUClast(Baseline to 30 days after the last dose of study treatment)
- Serious Adverse Events (SAEs)(Baseline to 45 days after the last dose of study treatment)
- Tmax(Baseline to 30 days after the last dose of study treatment)
- Cmax(Baseline to 30 days after the last dose of study treatment)
- Duration of Response (DoR)(Baseline to study completion (up to 24 months))
- Disease Control Rate (DCR)(Baseline to study completion (up to 24 months))
- Overall Survival (OS)(Baseline to study completion (up to 24 months))
- Incidence of anti-drug antibody (ADA)(Baseline to 30 days after the last dose of study treatment)
研究者
研究点 (2)
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