NCT07737600尚未招募1 期
Phase Ib/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of MRG007 Combination Therapy in Patients With Advanced Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
This is a Phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of MRG007 combination therapy in patients with advanced colorectal cancer.
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
- •Expected survival of ≥ 3 months.
- •Tumor tissue specimens must be provided for relevant biomarker testing. If archived tissue specimens are unavailable, a new biopsy must be performed.
- •Pathologically confirmed, unresectable locally advanced or metastatic colorectal adenocarcinoma.
- •At least one measurable lesion according to RECIST v1.1 criteria. Measurable lesions should not have received prior radiotherapy; however, measurable lesions located within a prior radiation field or after local therapy may be selected as target lesions if disease progression is confirmed.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- •Adequate organ function must be demonstrated.
- •Sexually active males and females of childbearing potential must agree to use highly effective contraceptive measures from the time of signing the informed consent form until 6 months after the last dose of the investigational drug. Females of childbearing potential include premenopausal females and postmenopausal females within 1 year after menopause. Females of childbearing potential must have a negative serum pregnancy test result ≤ 7 days prior to the first dose and before randomization.
排除标准
- •Trial participants with known deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H).
- •Trial participants with synchronous or multiple primary malignancies.
- •Residual toxicity ≥ Grade 2 resulting from prior anti-tumor therapy.
- •Symptomatic central nervous system (CNS) metastases and/or leptomeningeal metastases.
- •History of severe cardiovascular disease.
- •Cerebrovascular accident, pulmonary embolism, or deep vein thrombosis occurring within 3 months prior to the first dose of the investigational drug; thrombosis associated with implanted venous ports or catheters; or superficial vein thrombosis, except for patients with stable thrombosis after standard anticoagulation therapy. Prophylactic use of low-dose low-molecular-weight heparin is permitted.
- •Clinically symptomatic moderate or larger volume pleural, ascitic, or pelvic effusions requiring clinical intervention, or clinically symptomatic pericardial effusion.
- •History of gastrointestinal perforation and/or fistula within 6 months prior to the first dose of the investigational drug that has not healed following surgical treatment; risk of bowel obstruction or bowel perforation; extensive bowel resection; poorly controlled Crohn's disease, ulcerative colitis, or other gastrointestinal autoimmune or inflammatory diseases; presence of pyloric obstruction and/or persistent recurrent vomiting.
- •Active chronic hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
- •Hypersensitivity to any component or excipient of MRG007, or known ≥ Grade 3 hypersensitivity to other prior anti-CDH17 antibodies or other monoclonal antibodies.
- •Body weight loss ≥ 10% during the screening period. Any severe and/or uncontrolled systemic disease that, in the opinion of the investigator and the sponsor, renders the participant unsuitable for participation in this study.
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: From the first dose to 30 days after the last dose
Serious Adverse Events (SAEs)
时间窗: From the first dose to 30 days after the last dose
Adverse Event (AE)
时间窗: From the first dose to 30 days after the last dose
Recommended Phase 2 Dose(RP2D) and/or Maximum Tolerated Dose (MTD)
时间窗: From the first dose to 30 days after the last dose
Objective Response Rate (ORR)
时间窗: Assessments will be performed every 6 weeks (± 7 days) following the first dose.
次要结局
- PK/Immunogenicity(up to 2 yesrs)
- Duration of Response (DOR)(Through study completion, an average 2 years)
- Disease Control Rate (DCR)(Through study completion, an average 2 years)
- Progression-Free Survival (PFS)(Through study completion, an average 2 years)
- Overall Survival (OS)(Through study completion, an average 2 years)
- Serum Concentration(up to 2 years)
- Neutralizing antibody (NAb)(up to 2 years)
- Anti-Drug Antibody (ADA)(up to 2 years)
研究者
研究点 (1)
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