NCT07066657招募中1 期
An Open-Label, Multi-Center, Dose Escalation, Confirmation, and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of MRG007 (ARR-217) in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 572
- 试验地点
- 23
- 主要终点
- Dose Limiting Toxicity (DLT) - Phase Ia
研究概览
简要总结
This is an open-label, multi-center, phase I study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of MRG007 (ARR-217) in patients with unresectable locally advanced or metastatic solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to sign the informed consent form and follow the requirements specified in the protocol.
- •Life expectancy ≥ 3 months.
- •Tumor specimen available for CDH17 testing, or agree to biopsy at baseline.
- •Patients with histologically and cytologically confirmed advanced or metastatic solid tumor who have failed or intolerant to standard therapy, or without alternative standard therapy.
- •Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- •The score of ECOG for performance status is 0 or
- •Organ functions and coagulation function must meet the basic requirements.
- •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
- •Patients with more than one cancer.
- •Received CDH17-targeting anti-tumor therapy; received other investigational product, systemic corticosteroids or surgery for major organs within 4 weeks prior to the first dose; received anti-tumor therapy within 3 weeks or within 5 half-lives prior to the first dose, whichever is shorter; received radiotherapy within 2 weeks prior to the first dose; received strong CYP3A4 inducers or inhibitors within 2 weeks prior to the first dose or 5 half-lives, whichever is longer; investigational therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose.
- •≥Grade 2 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment
- •Symptomatic Central nervous system and/or meninges metastasis.
- •History of severe cardiovascular diseases
- •Cerebrovascular accident, pulmonary embolism, or deep venous thrombosis within 3 months prior to the first dose, implantable venous infusion port or catheter-related thrombosis, or superficial venous thrombosis
- •History of previous or combined interstitial pneumonia, current interstitial pneumonia, or suspected interstitial pneumonia that cannot be ruled out through imaging during screening, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary dysfunction, symptomatic bronchospasm, etc.
- •Poorly controlled pleural, peritoneal, and pelvic effusion, or combined pericardial effusion
- •Infection of active hepatitis B, active hepatitis C, or HIV
- •Uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections requiring intravenous anti-infection therapy within 2 weeks prior to the first study treatment
- •Known allergic reactions to any component of MRG007, or known Grade≥3 allergic reactions to other prior anti-CDH17 (including investigational) or other monoclonal antibody.
- •Other situations that are not suitable to participate a clinical trial per investigator's judgement
- •Additional protocol-defined exclusion criteria apply
研究组 & 干预措施
MRG007 and Bevacizumab
Experimental
干预措施: MRG007 and Bevacizumab (Drug)
MRG007
Experimental
干预措施: MRG007 (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT) - Phase Ia
时间窗: Baseline to Day 21 of the first treatment cycle
Treatment-Related Adverse Event
时间窗: Baseline to 30 days after the last dose of study treatment
Any reaction, side effect, or untoward event that occurs during the course of the clinical trial is considered related to the study drug.
Objective Response Rate (ORR) as assessed by investigator - Phase Ib
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.
Serious Adverse Events (SAEs)
时间窗: Baseline to 30 days after the last dose of study treatment
Adverse events that are fatal, life-threatening, or result in hospitalization or prolonged hospitalization, persistent or significant disability/incapacity/substantial disruption of the ability to lead a normal life, congenital anomaly/birth defect or major medical events or reactions
Treatment-Emergent Adverse Event (TEAE)
时间窗: Baseline to 30 days after the last dose of study treatment
AEs that occur or worsen on or after the first dose of study treatment
次要结局
- Cmax(Baseline to 30 days after the last dose of study treatment)
- AUC0-t(Baseline to 30 days after the last dose of study treatment)
- Disease Control Rate (DCR)(Baseline to study completion (up to 24 months))
- 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))
- 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.)
- Incidence of neutralizing antibody (NAb)(Baseline to 30 days after the last dose.)
- Tmax(Baseline to 30 days after the last dose of study treatment)
- QTc interval(Baseline to 30 days after the last dose of study treatment)
- Objective Response Rate (ORR) - Phase Ia(Baseline to study completion (up to 24 months))
- Disease Control Rate (DCR)(Baseline to study completion (up to 24 months))
- 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))
- 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.)
- Incidence of neutralizing antibody (NAb)(Baseline to 30 days after the last dose.)
- Tmax(Baseline to 30 days after the last dose of study treatment)
- Cmax(Baseline to 30 days after the last dose of study treatment)
- AUC0-t(Baseline to 30 days after the last dose of study treatment)
研究者
研究点 (23)
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